EPA-800/1-77-032
June 1977
Environmental Health Effects Research Series
                      EFFECTS OF  LOW LEVEL  CARBON
                                    MONOXIDE  EXPOSURE
                                          Blood  Lipids  and
                                 Coagulation Parameters
                                         Health Effects Research Laboratory
                                        Office of Research and Development
                                        U.S. Environmental Protection Agency
                                  Research Triangle Park, North Carolina  27711

-------
                RESEARCH REPORTING SERIES

Research reports of the Office of Research and Development, U.S. Environmental
Protection Agency, have been grouped into nine series. These nine broad cate-
gories were established to facilitate further development and application of en-
vironmental technology. Elimination of traditional grouping was consciously
planned to foster technology transfer and a maximum interface in related fields.
The nine series are:

      1   Environmental Health Effects Research
      2   Environmental Protection Technology
      3   Ecological Research
      4   Environmental Monitoring
      5.  Socioeconomic Environmental Studies
      6.  Scientific and Technical Assessment Reports (STAR)
      7   Interagency Energy-Environment Research and Development
      8.  'Special" Reports
      9   Miscellaneous Reports
This report has been assigned to the ENVIRONMENTAL HEALTH EFFECTS RE-
SEARCH series. This series describes projects and studies relating to the toler-
ances of man for unhealthful  substances or conditions. This work is generally
assessed from a medical viewpoint, including physiological or psychological
studies. In addition to toxicology and other medical specialities, study areas in-
clude biomedical  instrumentation and health research techniques utilizing ani-
mals — but always with intended application to human health measures.
This document is available to the public through the National Technical Informa-
tion Service, Springfield, Virginia  22161.

-------
                                          EPA-600/1-77-032
                                          June 1977
EFFECTS OF LOW LEVEL CARBON MONOXIDE EXPOSURE

   Blood Lipids and Coagulation Parameters
            K. M. Brinkhous, M.D.
           Department of Pathology
        University of North Carolina
      Chapel Hill, North Carolina 27514
           Contract No. 68-02-1281

              Project Officer

            Edward D. Haak, Jr.
        Clinical Studies Division
    Health Effects Research Laboratory
    Research Triangle Park, N.C. 27711
   U.S. ENVIRONMENTAL PROTECTION AGENCY
    OFFICE OF RESEARCH AND DEVELOPMENT
    HEALTH EFFECTS RESEARCH LABORATORY
    RESEARCH TRIANGLE PARK, N.C. 27711

-------
                           DISCLAIMER

     This report has been reviewed by the Health Effects Research
Laboratory, U.S. Environmental  Protection Agency, and approved for
publication.  Approval does not signify that the contents necessarily
reflect the views and policies  of the U.S. Environmental Protection
Agency, nor does mention of trade names or commercial products
constitute endorsement or recommendation for use.
                                ti

-------
                               FOREWORD

     The many benefits of our modern, developing,  industrial  society are
accompanied by certain hazards.   Careful  assessment of the relative risk
of existing and new man-made environmental  hazards is necessary for the
establishment of sound regulatory policy.  These regulations  serve to
enhance the quality of our environment in order to promote the public
health and welfare and the productive capacity of our Nation's population.

     The Health Effects Research Laboratory, Research Triangle Park,
conducts a coordinated environmental  health research program  in toxicology,
epidemiology, and clinical studies using human volunteer subjects.  These
studies address problems in air pollution,  non-ionizing radiation,
environmental carcinogenesis and the toxicology of pesticides as well as
other chemical pollutants.  The Laboratory develops and revises air quality
criteria documents on pollutants for which national ambient air quality
standards exist or are proposed, provides the data for registration of new
pesticides or proposed suspension of those already in use, conducts research
on hazardous and toxic materials, and is preparing the health basis for
non-ionizing radiation standards.  Direct support to the regulatory function
of the Agency is provided in the form of expert testimony and preparation of
affidavits as well as expert advice to the Administrator to assure the
adequacy of health care and surveillance of persons having suffered imminent
and substantial endangerment of their health.

     The report that follows is part of the Laboratory's research to
refine health information on exposure effects to pollutants for which
ambient air quality standards have been developed.
                                          JoFm H. Knelson, M.D.
                                               Director,
                                   Health Effects Research Laboratory

-------
ABSTRACT
     This study examined the effects of carbon monoxide (CO)  in 50 and TOO
ppm doses on response to treadmill  exercise,  blood coagulation and blood
lipids in normal men.  Twenty-three men were  exposed to CO or to air in a
double-blind protocol.   After exposure, each  underwent a graded exercise
treadmill test which was terminated at 85% maximal heart rate.  Blood for
measurement of carboxyhemoglobin (COHb), hematocrit, platelet count, prothrombin
time, partial thromboplastin time,  thrombin time,  fibrin split products, factor
VIII, platelet aggregation, serum cholesterol  and  triglycerides was drawn at
baseline, preexercise and postexercise.  COHb did  not change  on air days but
reached a mean of 2.17% on 50 ppm days and 4.15% on 100 ppm days.  The mean
duration of exercise was 19 sec shorter on CO days than on air days (f = 4.93).
The greatest effect was on 100 ppm days (f =  8.00).  Coagulation parameters
and cholesterol and triglyceride measurements were not significantly affected
by CO exposure.  Over the week of testing the cholesterol  and triglyceride
levels fell significantly and exercise was regularly associated with increased
factor VIII activity.  CO levels of 50 and 100 ppm significantly reduced the
duration of exercise to attainment of a target heart rate in  normal men.  No
effect of CO at these levels on coagulation parameters or on  serum cholesterol
and triglycerides was detected.
                                   IV

-------
INTRODUCTION
     The goal of this study was to detect the effects of carbon monoxide
in 50 ppm and 100 ppm doses on response to treadmill  exercise in normal  young
men on certain parameters of blood coagulation and on blood lipids.

METHODS
     Patient selection:  Informed consent was obtained from all subjects.
Twnety-three men less than 38 years of age were included in the study.  Each
was given a physical examination, and chest x-ray and electrocardiograms were
performed on every subject.  Men with evidence of organic heart disease of
any kind were excluded from the study.  Additionally, all subjects were asked
to refrain from cigarette smoking during the 12 hours before the beginning
of each exposure period.  Each subject was shown to have normal hematocrit,
platelet count, prothrombin time, partial thromboplastin time, thrombin clotting
time and factor VIII levels.
     Experimental protocol:  (Fig. 1) Each subject was studied on weekday
mornings.  Each fasted except for water during the 8 hours before the test
was performed.  At the beginning of the day, blood was drawn for baseline
coagulation and lipid determinations.  The subject then was exposed to air
with or without carbon monoxide via a closed system which included a tank of
gas with pressure regulators, a Douglas bag reservoir, and a tightly fitting
mask.  The exposure period was 4 hours.  On Monday and Friday mornings the
subjects were exposed to air only.  Tuesday through Thursday the gas was air,
air with carbon monoxide  (CO) at 50 ppm or air with CO at 100 ppm as determined
by one of the investigators.  The physician, the technicians and the subject
were unaware of the content of the gas while the experiment was progressing
and when the electrocardiograms were analyzed.

-------
     At the end of the 4 hours of exposure, blood was again drawn for
carboxyhemoglobin (COHb), coagulation factor and lipid analyses.   The subject
was then asked to walk on a treadmill until 85% maximal heart rate had been
achieved.  The treadmill was a programmed instrument set to advance at 3-minute
intervals from a speed of 2 mph to 10 mph and from no incline to  an incline
of 16°.  Heart rate was monitored by a Hewlett-Packard three-channel monitor
which recorded 12 leads of ECG at 1-minute intervals and by a telemetered
rate counter which computed the rate from the R-R interval.  When the latter
instrument indicated that 85% maximal heart rate as determined by the standard
tables was reached, the time and stage of exercise were recorded  and the
treadmill was stopped.  The subject again donated blood for analysis and the
ECG was continued until the baseline heart rate was achieved.  The ECG was
analyzed for heart rate and time.  Each subject was used as his own control
from day to day and the Monday and Friday tests were included to  document
any training effect.
     Coagulation factor assays:  Baseline blood samples were drawn at 8:00 a.m.
from both smokers and non-smokers prior to CO exposure.  Samples  were drawn
into heparin for COHb levels and into a si 1 iconized vacuum tube for blood
lipids and delivered immediately to the respective laboratories.   The samples
for blood coagulation studies were handled as follows:  blood was drawn into
3.2% sodium citrate at a ratio of 1:9 and immediately transported on ice to
the laboratory.  Hematocrit tubes and red cell pipettes were prepared with
whole fresh blood.  The hematocrit tubes were heparinized capillary tubes.
The hematocrit was immediately centrifuged on a microhematocrit centrifuge
for 5 minutes.  Values were obtained by the scale method and recorded in
duplicate.  One percent ammonium oxalate was used as platelet diluting fluid.

-------
Red cell pipettes containing the diluted blood sample were returned to the
coagulation laboratory and platelet counts were made by the method of Brecher,
et al (Am. J.  Clin. Path., 23: 15-26, 1953).
     The anticoagulated blood for coagulation analyses was spun in plastic
disposable tubes (17 x 100 mm) at 150 x g in  an Adams Dynac centrifuge for
10 minutes at room temperature, and sufficient platelet-rich plasma (PRP) was
aspirated for platelet aggregation studies.  This sample remained at room
temperature and the platelet aggregating assay was performed immediately.
The remaining plasma sample was re-mixed and  re-centrifuged at 1500 x g in
the Adams Dynac centrifuge.  The plasma was immediately aspirated, aliquoted,
labelled and frozen in a -70° refrigerator for other coagulation studies to
be performed at a later time.
     Platelet aggregating assays were performed using a Payton Dual Channel
Aggregation Module and a Bausch & Lomb VO-5 Recorder.  The PRP was added to
the cuvette (0.45 ml) and allowed to mix for  1 minute before serial dilutions
of 0.05 M epinephrine (Parke Davis Adrenalin  Chloride Solution) were added.
Results were tabulated, charted and recorded.
     The coagulation factor assays were done  on the fresh frozen samples
several days later.  The tests were performed using usual laboratory reagents
and Hyland Reference Plasma (Hyland Laboratories, Costa Mesa, California) as
a normal control.
     For the prothrombin time (PT) plasma samples were removed from the -70°
refrigerator and thawed in a waterbath at 37°.  Simplastin (General Diagnostics,
Morris Plains, N.J.) was placed in a test tube and into the waterbath.  After
thawing, the plasma was removed and placed at room temperature.  One tenth ml
of the plasma was added to a 10 x 75 mm disposable culture tube and incubated

-------
at 37° for 30 sec.  At the end of this period, 0.2 ml of Simplastin was
added and the stopwatch started.  The sample was immediately removed from
the waterbath and tilted until fibrin strands began to form.  The test and
control samples were done in duplicate and recorded.  The normal control
PT fell between 12 and 14 sec.
     For the partial thromboplastin time (PTT), plasma samples were thawed
in the 37° waterbath.  Test tubes of undiluted Thrombofax (Ortho Pharmaceutical,
Raritan, N.H.) and 0.02 M CaCl were placed in the waterbath.  After thawing,
the plasma samples were held at room temperature.  One tenth ml of plasma was
added to a 10 x 75 mm disposable culture tube and incubated for 60 sec at
37°.   At the end of 60 sec, 0.1 ml of Thrombofax and 0.1 ml of 0.02 M CaCl
were added and the stopwatch started.  The sample remained in the waterbath
for 45 sec before being removed and tilted.  The test samples and reference
normals were done in duplicate and recorded.  The normal clotting times fell
between 40 and 60 sec.
     The thrombin clotting time (TCT) was performed at room temperature with
plasma which had been thawed-in a 37° waterbath.  Two tenths ml of plasma was
added to a 10 x 75 mm disposable culture tube followed immediately by addition
of 0.2 ml of thrombin (10 units/ml) (Parke, Davis, and Co., Detroit, Michigan),
and the stopwatch was immediately started.   This test along with the
reference normal was done in duplicate.   The normal TCT ranged from 12 to
14 sec.
     The plasma factor VIII (antihemophilic factor) assay was based upon
the observation that the PTT of hemophilic plasma is prolonged and the degree
of correction of this prolonged time is proportional to the factor VIII
concentration of the plasma sample added as test material.  Hemophilic blood

-------
(substrate) was drawn from a patient with severe classic hemophilia Into
                                    '•'£
3.2% sodium citrate at a ratio of 1:9.   The plasma was prepared by spinning
the whole blood at 1500 x g for 10 minutes, RT.   Hemophilia plasma samples
were aliquoted and frozen at -70°.
     For the factor VIII assay, Thrombofax diluted 1:10 with normal saline
was used as the partial thromboplastin.  Citrated saline was used as a
buffered diluting fluid and referred to as the human diluent.  It was composed
of one part 0.2% normal saline, one part imidazole buffer (pH 7.2) and 0.4
part 3.2% trisodium citrate.  Calcium was added to the system by means of
calcium-imidazole-saline (C-I-S) [1.4 parts of 1.2% CaCl and one part of 0.9%
saline were added to 1.2 parts imidazole buffer (pH 7.2)].  The plasma samples •
were activated with kaolin (Fisher Scientific Co., Fair Lawn, N.H.).
     Test and hemophilic plasmas were thawed at 37°.  Hyland reference plasma
was prepared following container directions.  Serial dilutions of 10%, 5%,
2,.5%  and 1.25% were made with both test and control plasmas.  The plasmas
were mixed with 10 mg/ml kaolin, capped and incubated at room temperature
for 15 minutes, tilting every 2 minutes to keep the kaolin suspended.  The
C-I-S mixture and the diluted Thrombofax were placed in test tubes, labelled
and incubated in the 37° waterbath.  After a 15-minute waiting period, the
activated plasmas were placed on ice and left for at least 5 minutes before
starting the test.  Determinations of the PTT's of the plasma samples began
with the 10% dilution of control followed by the 10% dilution of the test, etc.
All testing was done in duplicate.
     Two tenths ml of plasma mixture was placed in a 37° waterbath in a 10 x 75 mm
tube and incubated for 30 sec.  Upon completion of the 30 sec, 0.1 Thrombofax
and 0.1 ml C-I-S mixture were added and a stopwatch started.  The tubes remained

-------
in the waterbath for 60 sec but were tilted after the first 30 sec.   At
the end of 60 sec the tubes were removed and tilted until  the fibrin formation
began.  The stopwatch was stopped and times recorded when  fibrin strands
were noted.  The duplicate PTT's were averaged.   Using semi logarithmic
paper, the plasma concentrations were plotted on the logarithmic scale against
the PTT's on the arithmetic scale.   The control  points were connected forming
a straight line.  Factor VIII activity was calculated by comparing the
relative concentrations of normal and test plasmas at time points on the
parallel graphic lines.
     Fibrin split products were assayed by a latex particle agglutination
method.  Five ml of whole blood was drawn at baseline, preexercise and
postexercise and allowed to clot.  EACA was present in the tube to prevent
fibrinolysis.  The serum was allowed to» incubate at room temperature for
24 hours.  At the. end of this period the sample was centrifuged and the
serum aspirated, aliquoted and frozen.  At the time of testing the samples
were thawed and diluted with glycine saline buffer in serial dilutions from
1:1 - 1:64.  Special glass slides obtained from Burroughs-Well come Co.,
Research Triangle Park, N.C., were for checking agglutination.  One drop of
patient serum was placed on a glass slide and one drop of  latex suspension
(Burroughs-Wellcome Co., Research Triangle Park, N.C.) added.  The glass
slide was tilted back and forth checking for agglutinating particles.
Agglutination in samples diluted more than 1:8 was considered positive and
reported as the highest dilution at which agglutination occurred.
RESULTS
     A total of 23 normal young men were studied.  There were 15 men who
denied use of more than five cigarettes per day.  This group will be referred

-------
to as nonsmokers.  Eight subjects were smokers.  These two groups of subjects
will for the most part be considered separately.  In the group of nonsmokers
the mean age was 26.2 years with a median of 25 years and a range from 20 to
38 years.  The smokers had a mean age of 24.25 years with a median of 26
years and a range of 20 to 33 years.
     Carbon monoxide levels:  Nonsmokers had baseline carboxyhemoglobin levels
which ranged from zero to 1.55% with a mean of 0.52%.  The baseline levels
were not significantly different from day to day (Table 1).
     On days when the nonsmoking subjects were exposed to air containing no
CO the COHb levels did not significantly change during the exposure period.
Immediately after the period of exposure to CO at 50 ppm the mean COHb level
in the nonsmokers.was 2.75 ± 0.90%.  After exposure to 100 ppm the level in
nonsmokers was 4.72. ± 1.49%.  The levels in nonsmokers after exercise on days
when exposure was.to air only were not significantly changed.  Postexercise
levels on days when the subjects were exposed to 50 and 100 ppm had decreased
from preexercise values slightly to 2.53 ± 0.74% and 4.27 ± 1.21% respectively.
This slight decrease was statistically significant.
     Smokers had a mean COHb at the baseline that was 1.06 units higher than
that of nonsmokers on the average (Table 2).  After exposure to 50 ppm the
mean COHb level was 3.42 ± 0.94% and after 100 ppm it was 5.32 ± 1.23%.  These
levels dropped slightly to 3.07 ± 0.79% and 5.04 ± 1.26% after exercise.
     Table 3 shows the combined data on smokers and nonsmokers and indicates
the significantly increased levels of COHb on the CO exposure days.  The
average increase in COHb from baseline to preexercise for the two CO days
was 3.16% more than for the three air days.  On the 50 ppm day this increase
was  2.17% while on the 100 ppm day it was 4.15%.  The 1.98% increase on the
100 ppm day over the 50 ppm day was significant.

-------
     Exercise tolerance:  Figure 4 shows the exercise tolerance in seconds
on the 5 days of the study for nonsmokers.   The data concerning exercise
tolerance in smokers is shown in Figure 5.   There was no significant difference
between smokers and nonsmokers with respect to time required to reach 85%
of predicted maximal heart rate.
     Comparison of exercise tolerance on days when subjects were exposed to
CO with that on days when the exposure was  to air only shows a significantly
shorter duration of exercise to achievement of 85% maximal  heart rate on CO
days.  On CO days the mean exercise time was 488 sec as compared with 507 sec
on air days.  The difference between exercise times on air days and on days
with exposure to 50 ppm was not significant while that between air days and
CO days with 100 ppm was significant.
   •  Blood lipids:  No differences in cholesterol levels"were noted to be
related to CO exposure (Table 6).   There was, however, a significantly lower
level on Friday than on Monday.  This difference was an average of 9 mg %.
The triglyceride level also fell by an average 17 mg % across the 5-day
period.  No change in triglyceride levels could be related to CO exposure
(Table 7).
     Blood coagulation parameters:  Prothrombin times, partial thromboplastin
times, thrombin clotting times and fibrin split product titers were never
outside the range of normal and daily variation in our tests made it
impossible to correlate changes with exercise or presence or absence of carbon
monoxide in the inspired air.
     Factor VIII;  The factor VIII levels increased significantly from
preexercise to postexercise values (Table 8).  There was, however, no
significantly greater increase on CO days than on air days.  Although not
significant (p = 0.157) the difference between smokers and nonsmokers was
                                    8

-------
rather large.  The mean for smokers was 85.7% and the mean for nonsmokers
was 100.6%.  This apparent difference deserves further study.
     Hematocrvt:  On the three air days, the mean hematocrit increased 0.8%
from preexercise to postexercise (Table 9).   This increase was significant.
On the CO days, this increase was 0.9% which again was significant.   There
was an increase of 1.3% on the 50 ppm day which makes it unlikely that an
effect of CO exposure on the differences in hematocrit levels  before and
after exercise can be implied.
     Platelet count:  There was a large but not significant (p = 0.075)
difference between the platelet counts of smokers and nonsmokers.  The
                                        3                                 3
mean count for nonsmokers was 225,000/mm , that for smokers was 253,000/mm .
Additionally, there was significant increase in platelet counts in all groups
between the preexercise and postexercise sampling periods (Table 10).  The
mean increase on the three air days was 15,300/mm , the increase on the 50
                                   3
ppm day was an average of 37,000/mm  and the increase on 100 ppm days was
         3
19.300/mm .  The difference between the increase on air days and the increase
                            3
on, the 50 ppm day, 22,500/mm , was significant.
     Platelet aggregation studies were performed on 5 subjects.  These
studies showed no effect of exercise or carbon monoxide on platelet aggre-
gation to ADP or epinephrine in our system.
DISCUSSION
     The validity of this study is dependent to a great extent upon the
comparability of the study subjects and, therefore, is potentially threatened
by the presence among the study group of both smokers and nonsmokers.
Smokers, for instance, had an average baseline COHb level that was 1.06%
higher than that of the nonsmokers.  Subsequent measurements were proportionally

-------
different between the smokers and nonsmokers.   This problem has been signifi-
cantly abated, however, by the use of paired t analysis allowing comparison
of each variant in a single subject.  Even though variability between subjects
prevented the description of an effect of smoking on the parameters measured,
within each subject there was measured an effect of carbon monoxide exposure
over and above that attributable to the smoking.
     Carbon monoxide exposure primarily influenced exercise tolerance.   A
significantly decreased time to attainment of 85% of maximal  heart rate was
demonstrated on days when the subjects had been exposed to carbon monoxide.
The carboxyhemoglobin level at which this effect was noted was 4.93%.  These
results are similar to those reported by others and imply that carbon monoxide
even in relatively small doses will decrease the peak work production of
normal young men.  Of special note is a demonstrable effect of added CO in
smokers similar to that of nonsmokers.
     These findings show a physiologic effect of carboxyhemoglobin at very
low levels.  The effect is possibly related to an increased requirement for
peripheral blood, flow because of a decreased availability of oxygen for
respiration.  The exact mechanism by which increased heart rate precipitated
by carbon monoxide exposure at a certain level of exertion is mediated is,
of course, unknown.  The fact that such an effect can be measured at submaximal
exertion, however, implies that the workload to be met by the cardiovascular
system can be significantly augmented by even very small doses of carbon
monoxide.
     To further characterize the physiologic effects of carbon monoxide,
blood lipids and coagulation measures were determined.  The serum cholesterol
and triglyceride levels were not affected by exposure to carbon monoxide or
by sutanaximal exercise following carbon monoxide exposure.

-------
     Previous studies on animals have shown increased serum cholesterol
levels after weeks of exposure to carbon monoxide.   It has also been shown
that cigarette smokers have slightly higher cholesterol  levels than do
nonsmokers.  The fact that no change was observed in our subjects may mean
that CO has no hyperlipidemic effect in humans.   More likely is the possibility
that such an effect cannot be demonstrated after an exposure period of only
4 hours and at levels as low as those used in this  study.
     To study the effects of carbon monoxide on the coagulation system we
chose to examine the routinely used clotting "screening tests" which include
prothrombin time, partial thromboplastin time, thrombin clotting time and
fibrin split products.  Additionally, we examined the phase reactant and
"consumable" factor VIII because of its known variability in response to a
number of interventions.  Specifically we wished to determine if the known
increase in plasma factor VIII levels caused by exercise would be augmented
by the. presence of carboxyhemoglobin.  The screening tests showed no change
with either CO exposure or exercise.  This result was related to the poor
sensitivity of the test procedure.  It should be remembered for instance
that more than a 20% fall in a clotting factor is required before it can be
detected by the screening tests.  Finally the use of screening tests to
measure "hypercoagulability" is unacceptable because of the known variability
among laboratories and the absence of consensus as  to the definition of the
term "hypercoagulability".  Therefore, there is no  major alteration in the
clotting system attributable to short-term, low-dose carbon monoxide exposure.
     Factor VIII assays, unlike screening assays, are relatively sensitive to
small changes in the plasma level of this factor.  Additionally, the plasma
factor VIII is known to decrease rapidly in the face of intravascular coagulation
                                   11

-------
and to increase with exercise, catacholanrine infusions or infection.  This
study shows that chronic smoking is associated with a slight but not statisti-
cally significant decrease in factor VIII levels below the normal level.  This
difference between smokers and nonsmokers has not been previously described
and deserves further study.  There was a significant increase in factor VIII
levels between the preexercise period and the postexercise period as expected.
However, no difference was noted between the increases recorded on air days
and those which occurred on CO days.  These studies do not rule out the
possibility that at higher doses of CO some effect on factor VIII might be
noted.  They do indicate that no demonstrable effect occurs at levels which
are of interest to environmental planners.
     Finally, an attempt was made to measure the effects of carbon monoxide
exposure and exercise on platelet function.  Platelet counts were made on
each blood sample.  There was a large but not statistically significant
difference between smokers and nonsmokers with the mean level among the smokers
being 28,000 platelets/mm  higher.   This difference has not been noted in the
past.  There was a singificant increase in platelet counts between the
preexercise and postexercise measurements,  but no reproducible effect of
carbon monoxide was noted.  The low-dose and short-term of exposure to
carbon monoxide may have allowed potential  effects on platelet concentration
to go undetected.   There was, however, no marked effect demonstrated by this
study.
     Platelet aggregometry was attempted on the first several study subjects.
The blood sample size,  the need for collection of simultaneous control studies
and the long period of uninterrupted testing necessary to do these studies
prohibited the assay of this variable in all subjects.  No effect on platelet
aggregation of either exercise or CO was detected.
                                   12

-------
     Study of patients with coronary heart disease  was  begun  during  the  first
half of 1976.  At that time two studies  were completed.   The  second  patient
suffered an episode of prolonged chest pain which required admission to  the
coronary care unit.  Because of this occurrence,  the study was  suspended
until the Protection of the Rights of Human Subjects authorization could be
reviewed and reevaluated.   This review is presently in  process.
     In summary, these studies have demonstrated  a  dose-related increase
in heart rate with standardized exercise in normal  young men.  This  effect
was noted at carboxyhemoglobin levels of 4% on the average which was accumu-
lated over a 4-hour period.  The study was sound  in that double-blind admini-
stration of air and air containing carbon monoxide prohibited the prejudicial
performance of subjects and the prior knowledge of investigators. Additionally,
the study was conducted over a 5-day period which allowed for the evaluation
of training effect.  Simultaneous studies of blood lipids and coagulation-
screening tests as well as more sensitive measures of coagulation failed to
link changes in these parameters to the presence  in the inspired air of
carbon monoxide.  These results indicate that levels of carbon monoxide  in
the atmosphere as low as 50 to 100 ppm limit the  ability to perform  submaximal
activity.  There is, however, no detectable effect of carbon  monoxide at
these levels on blood lipids or coagulation parameters.   The  possibility
that effects may exist after exposure to higher doses of carbon monoxide
for longer periods cannot be ruled out by our study.
                                   13

-------
                                      Figure  1.   PROTOCOL
 Gas Exposure:   4-hour exposure via closed face mask with subject sitting in a chair.
            Day
            Type
             of
          Exposure
Mon.
Tues.
                        clean
                         air
Wed.
                       clean
                        air
                    -Test for-
                     Training
                      Effect
Thurs,
Fri.
                                         Randomized between
                                         50 ppm in clean air &
                                         100 ppm in clean air
                                     clean
                                      air
Typical Day:
                                      8:00 a.m.--Basel
                             ine I—
                                                   4-Hour
                                                Gas Exposure
      EKG monitoring
      EKG recordings
      BP monitoring
      Heart rate monitoring
      Exercise time
                                •-- 12:00 Noon--Preexer,cise
                        Exercise
                          Test
                                        Postexercise
                              Blood sample for:

                              1), COHb level
                              2) Blood lipids:
                                 a.  cholesterol
                                 b.  triglycerides
                              3) Blood clotting studies:
                                 a.  platelet function
                                 b.  Factor VIII level,
                                     etc.
                                             14

-------
                            Table 1
COHb (Nonsmokers)

Baseline
S.D.
Preexercise
S.D.
Postexercise
S.D.
Monday
0.47
0.54
0.31
0.36
0.48
0.29
X
0.64
0.47
0.70
0.42
0.61
0.41
Friday
0.52
0.30
0.51
0.32
0.62
0.31
50 ppm
0.54
0.47
2.75
0.90
2.53
0.74
100 ppi
0.52
0.46
4.72
1.49
4.27
1.21
       15

-------
                              COHb (Smokers)
                                                           Table  2
Baseline
  S.D.

Preexercise
  S.D.

Postexercise
  S.D.
Monday
 2.06
 1.50

 1.51
 0.88

 1.38
 0.95
2.18
0.87

1.65
0.59

1.47
0.72
Friday
 2.28
 0.97

 1,70
 0.90

 1.51
 0.65
                                                           50  ppm    100  ppm
1.88
1.13

3.42
0.94

3.07
0.79
1.82
0.80

5.32
1.23

5.04
1.26
                                    16

-------
                              COHb (Combined)
                                                        Table  3
Baseline
Preexercise
Mean
S.D.

Mean
S.D.
Postexercise     Mean
                 S.D.
Monday
 1.02
 1.22

 0.72
 0.82
 0.79
 0.73
1.17
0.97

1.03
0.66

0.91
0.67
Friday
 1.07
 0.99

 0.93
 0.81
 0.93
 0.62
                                                           50  ppm    100  ppm
1.00
0.99

2.98
0.95

2.72
0.78
0.97
0.86

4.93
1.40

4.54
1.25
                                    17

-------
                          Table  4
Nonsmokers
iubject

J.W.
J.L.
G.W.
S.G.
N.W.
T.H.
S.R.
A.D.
B.Y.
M.P.
I.E.
I.E.
W.R.
C.S.
T.M.
Mean
Median
Age

31
29
38
24
22
29
20
23
24
20
30
22
25
26
30
26.2
25
Peak
H.R.

165
165
160
170
175
175
180
175
170
180
165
180
170
170
165
Mean
S.D.
Exercise Time (sec)
Mon
410
615
590
434
515
533
510
501
339
590
394
690
410
447
395
492
99
X
315
615
610
470
535
523
501
469
327
554
495
750
614
470
410
511
113
Fri
330
590
580
576
510
543
503
465
360
467
405
750
672
520
430
513
112
50 ppm
305
560
600
511
500
575
501
492
300
513
431
720
499
405
420
489
108
100 ppm
305
625
590
350
500
493
472
495
285
538
385
605
616
424
397
472
112
    18

-------
                     Table  5
Smokers
           Exercise Time (sec)
Subject

H.R.
J.H.
C.S.
VI. N.
D.F.
D.P.
C.K.
B.F.
Mean
Median
Age

33
22,
24- -
25
26
22
20
22
24.25
24
Peak
H.R.

165
180
170
(159-149)
170
180
180
180
Mean
S.D.
Air Days
Mon
470
—
315

529
577
594
617
517
112
X
505
435
310

405
531
544
760
499
141
Fri
512
435
300

480
558
605
780
524
149
CO Exposure Days
50 ppm
485
433
317

515
499
615
786
521
147
100 ppm
480
440
265

462
516
533
699
485
129
  19

-------
                                Cholesterol
                                                      Table 6
                          Monday
Friday
50 ppm    100 ppm
Baseline
Preexercise
Postexercise     Mean
Mean
S.D.
Mean
S.D.
Mean
S.D.
196
39
206
45
210
41
198
32
203
36
206
45
192
28
194
32
199
24
205
33
200
31
206
29
197
37
205
42
198
33
                                    20

-------
                               Triglycerides
                                                    Table 7
                          Monday
Friday
50 ppm    100 ppm
Baseline
Preexercise
Postexercise     Mean
Mean
S.D.
Mean
S.D.
Mean
S.D.
115
52
118
61
124
64
128
59
106
56
107
49
109
45
97
44
99
46
117
50
100
50
103
47
125
65
in
62
115
56
                                    21

-------
                                Factor VIII
                                                 Table 8
Baseline
Preexercise
Mean
S.D.

Mean
S.D.
Postexercise     Mean
                 S.D.
Monday
  93
  33

  89
  34

 m
  36
 87
 23

 82
 32

106
 34
Friday
  91
  29

  85
  33

 110
  34
                                                           50 ppm    100  ppm
 89
 24
 29

109
 29
 90
 34

 84
 25

114
 31
                                    22

-------
                                Hematocrit
                                                   Table 9
Baseline
Preexerci.se
Mean
S.D.

Mean
S.D.
Postexercise     Mean
                 S.D.
Monday
 45.5
  3.2

 46.3
  3.3

 47.7
  3.2
44.5
 2.6

44.8
 3.3

45.3
 2.9
Friday
 42.9
  2.3

 43.0
  2.5

 43.5
  3.2
                                                           50 ppm    100 ppm
44.5
 3.3

44.0
 3.4

45.3
 3.6
45.0
 3.5

45.1
 3.2

45.5
 3.1
                                    23

-------
                                                      Table  10
                              Platelet Count
                                 3
                          (per mm  in  thousands)
                          Monday
Friday
50 ppm    100 ppm
Baseline
Preexercise
Postexercise     Mean
Mean
S.D.
Mean
S.D.
Mean
S.D.
233
54
231
52
238
46
225
41
231
43
240
40
236
53
228
41
258
55
235
47
217
39
255
55
235
39
227
41
246
39
                                    24

-------
                                   TECHNICAL REPORT DATA
                            (Please read Instructions on the reverse before completing)
1. REPORT-NO.
 'EPA3600/T*77-:032
                                                           3. RECIPIENT'S ACCESSIONTMO.
4.iT..ITL€ AND SUBTITLE
 EFFECTS OF LOW LEVEL  CARBON MONOXIDE EXPOSURE
 Blood Li pids and  Coagulation Parameters
                                                           5. REPORT DATE
                                                            June  1977
              6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)

.K.' M?"Brinkhouse,  M.D.
                                                           8. PERFORMING ORGANIZATION REPORT NO.
9. RERFORMINQ1ORGANIZATION NAME AND ADDRESS

cDepartment of Pathology
'.University ,of North  Carol ina
iChapel••Hll.,1, N.C.  27514
               10. PROGRAM ELEMENT NO.

                1AA6Q1 	
               11. CONTRACT/GRANT NO.
                68-02-1281
1:2i:SPONSORING AGENCY NAME AND ADDRESS
.Healith" Effects Research Laboratory
fO'ff,ice 'ofyResearch  and Development
.B.SJ! .Environmental  Protection Agency
.:ResearcHi--Tp.iangle Park. N.C. 27711
                                                           13. TYPE OF REPORT AND PERIOD COVERED
RTP, NC
               14. SPONSORING AGENCY CODE
                EPA 600/11
15. SUPPLEMENTARY NOTES
16KABST\RACT
    Thlhists'tudy examined the effects of carbon  monoxide (CO) in 50  and 100 ppm doses
^orrar,esponse to. treadmill exercise, blood coagulation and blood lipids  in normal men.
'Twentyrthree men were  exposed to CO or to  air in a double-blind protocol.   After
^exposure?fieach underwent a graded exercise treadmill test which was  terminated at
:i85feGma»iiiial- heart  rate.   Blood for measurement  of carboxyhemoglobin  (COHb), hematocrit
plateletccount, prothrombin time, partial  thromboplastin time, thrombin time, fibrin
csp tit-products, factor VIII, platelet aggregation, serum cholesterol and triglycerides
:.wasirdrawai:at baseline, preexereise and postexercise.  COHb did not change on air days
.teut.reached a-mean of  2:17% on 50 ppm days and  4.15% on 100 ppm days    The mean
.duration;vof exercise was 19 sec shorter on CO days than on air days  (f = 4 93)  The
greatest-e-ffeet was on 100 ppm days (f = 8.00).   Coagulation parameters and
xilol;este'r?ol and triglyceride measurements  were  not significantly affected  by CO
f a target heart rate in normal  men.   No effect of CO at these levels
lonreo.agulation parameters or on serum cholesterol  and triglycerides was detected.
17.
                                KEY WORDS AND DOCUMENT ANALYSIS
                  DESCRIPTORS
                                              b.lDENTIFIERS/OPEN ENDED TERMS
                            c.  COSATI Field/Group
carbon-monoxide
bliood. coagulation
lipids
                              06,  F
                              06,  T
                              06,  S
air.pollution
13. DISTRIBUTION STATEMENT
 -RELEASE.TO  PUBLIC
                                              19. SECURITY CLASS (ThisReport)

                                                UNP.I ASSTFTFD
                            21. NO. OF PAGES

                               29
                                              20. SECURITY CLASS (Thispage)
                                                UNCLASSIFIED
                                                                         22. PRICE
EPA Form 2220-1 (9-73)
                                             25

-------
                                                      INSTRUCTIONS

  1.   REPORT NUMBER
      Insert the EPA report number as it appears on the cover of the publication.

  2.   LEAVE BLANK

  3.   RECIPIENTS ACCESSION NUMBER
      Reserved for use by each report recipient.

  4.   TITLE AND SUBTITLE
      Title should indicate clearly and briefly the subject coverage of the report, and be displayed prominently. Set subtitle, if used, in smaller
      type or otherwise subordinate it to main title. When a report is prepared in more than one volume, repeat the primary title, add volume
      number and include subtitle for the specific title.

  5.   REPORT DATE
      Each report shall carry a date indicating at least month and year. Indicate the basis on which it was selected (e.g., date of issue, date of
      approval, date of preparation,  etc.).

  6.   PERFORMING ORGANIZATION CODE
      Leave blank.

  7.   AUTHOR(S)
      Give name(s) in conventional order (John R. Doe, J. Robert Doe, etc.).  List author's affiliation if it differs from the performing organi-
      zation.

  8.   PERFORMING ORGANIZATION REPORT NUMBER
      Insert if performing organization wishes to assign this number.

  9.   PERFORMING ORGANIZATION NAME AND ADDRESS
      Give name, street, city, state, and ZIP code. List  no more than two levels of an organizational hirearchy.

  10.  PROGRAM ELEMENT-NUMBER
      Use the program element number under which the report was prepared. Subordinate numbers may be included in parentheses.

  11.  CONTRACT/GRANT NUMBER
      Insert contract or grant number under which report was prepared.

  12.  SPONSORING AGENCY NAME AND ADDRESS
      Include ZIP code.

  13.  TY'PE OF RiEPORT AND PERIOD COVERED
      Indicate interim final, etc., and if applicable, dates covered.

  14.  SPONSORING AGENCY CODE
      Leave *lank.

  15.  .SUPPLEMENTARY NOTES
      Enter information not included elsewhere but useful, such as:  Prepared in cooperation with, Translation of, Presented at conference of,
     ' To be published in, Supersedes, Supplements, etc.

  16:  ABSTRACT
      Include, a. brief (200 -words or less) factual summary of the most significant information contained in the report. If the report contains a
      significant bibliography or literature survey, mention it here.

  17. 'KEYWORDS AND DOCUMENT ANALYSIS
     : (a) 'DESCRIPTORS - Select from the  Thesaurus of Engineering and Scientific Terms the proper authorized terms that identify the major
      concept of the .research and are sufficiently specific and precise to be used as index entries for cataloging.

      (b)'lDENTIFIERS AND OPEN-ENDED TERMS - Use identifiers for project names, code names, equipment designators, etc. Use open-
      ended terms written in descriptor form for those subjects for which no descriptor exists.

      (c)iGOSAH FIELD GROUP -  Field and group assignments are to be taken from the 1965 COSATI Subject Category List. Since the ma-
      jority of documents are multidisciplinary in nature, the Primary Field/Group assignment(s) will be specific discipline, area of human
      endeavor, or type of physical object.  The application(s) will be cross-referenced with secondary Field/Group assignments that will follow
      the'primary ppsting(s).

  18.  DISTRIBUTION STATEMENT
      Denote releasability to the public or limitation for reasons other than security for example "Release Unlimited." Cite any availability to
      the public, with address  and price.

  19. & 20.  SECURITY CLASSIFICATION
      DO NOT submit classified reports to the National Technical Information service.

  21.  NUMBER OF PAGES
      Insert the total number of pages, including this one and unnumbered pages, but exclude distribution list, if any.

  22.  PRICE
     . Insert the price set by the National Technical Information Service or the Government Printing Office, if known.
A Form 2220-1 (9-73) (Remne)

-------