Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation
NCT ID: NCT01066923
Last Updated: 2017-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2010-02-28
2011-06-30
Brief Summary
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Detailed Description
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Fire suppression activities exacerbate cardiovascular strain and endothelial dysfunction and provide potential triggers for ischemic events (e.g. myocardial infarction, stroke). There is a rapid rise in heart rate following the activation of a fire company which may persist for as long as 20 minutes. Even in cases where heavy work is not being performed, the repetitive upper body exercise associated with tool use raises heart rate disproportionately to oxygen consumption.
Finally, there is a rapid rise in core body temperature from increased physical activity, environmental heat and impaired thermoregulation that has been shown to cause vasoconstriction and activate coagulation during heat stress (12, 13). This has recently been demonstrated in firefighters working in thermal protective clothing. The combination of triggers created during fire suppression may result in heart attack or stroke, especially in firefighters with risk factors for cardiovascular disease.
Interventions beyond basic fireground rehab may be required to minimize the effect of these triggers and enhance a firefighter's health and wellness. Fireground rehab typically focuses on cooling and rehydration of the firefighter following fire suppression or training with the assumption that these interventions will correct the underlying pathophysiology. Effective fireground rehab must deliver appropriate interventions and monitor the progress of the firefighter. While correcting hyperthermia and hypohydration are essential for continued performance, it is not clear if these therapies correct alterations in platelet or endothelial function or if other interventions are necessary to correct these physiological disturbances. Furthermore, the options for monitoring the firefighter beyond simply measuring heart and respiratory rate are limited. In our FEMA-funded Fireground Rehab Evaluation (FIRE) Trial, we demonstrated that five commercially available thermometers did not reliably measure or estimate core temperature following uncompensable heat stress (UHS) making it impossible to gauge the effectiveness of rehab interventions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Daily ASA, Active cool, Acute ASA
Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA)
Two weeks 82 mg aspirin taken orally prior to exercise protocol
Active cooling
Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water
Acute aspirin (ASA)
325 mg chewable aspirin administered immediately following exercise
Daily ASA, Active cool, Acute placebo
Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA)
Two weeks 82 mg aspirin taken orally prior to exercise protocol
Active cooling
Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water
Acute placebo
Placebo comparator for acute aspirin therapy
Daily ASA, Passive cool, Acute ASA
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Daily aspirin (ASA)
Two weeks 82 mg aspirin taken orally prior to exercise protocol
Acute aspirin (ASA)
325 mg chewable aspirin administered immediately following exercise
Passive cooling
Removing protective garments for passive cooling following exercise
Daily ASA, Passive cool, Acute placebo
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Daily aspirin (ASA)
Two weeks 82 mg aspirin taken orally prior to exercise protocol
Passive cooling
Removing protective garments for passive cooling following exercise
Acute placebo
Placebo comparator for acute aspirin therapy
Daily placebo, active cool, Acute ASA
Two weeks of daily placebo prior to exercise, active cooling following exercise, aspirin immediately post exercise
Active cooling
Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water
Acute aspirin (ASA)
325 mg chewable aspirin administered immediately following exercise
Daily placebo
Placebo comparator for daily aspirin therapy
Daily placebo, active cool, Acute placebo
Two weeks of daily placebo prior to exercise, active cooling following exercise, placebo immediately post exercise
Active cooling
Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water
Daily placebo
Placebo comparator for daily aspirin therapy
Acute placebo
Placebo comparator for acute aspirin therapy
Daily placebo, Passive cool, Acute ASA
Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Acute aspirin (ASA)
325 mg chewable aspirin administered immediately following exercise
Passive cooling
Removing protective garments for passive cooling following exercise
Daily placebo
Placebo comparator for daily aspirin therapy
Daily placebo, Passive cool, Acute placebo
Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Passive cooling
Removing protective garments for passive cooling following exercise
Daily placebo
Placebo comparator for daily aspirin therapy
Acute placebo
Placebo comparator for acute aspirin therapy
Interventions
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Daily aspirin (ASA)
Two weeks 82 mg aspirin taken orally prior to exercise protocol
Active cooling
Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water
Acute aspirin (ASA)
325 mg chewable aspirin administered immediately following exercise
Passive cooling
Removing protective garments for passive cooling following exercise
Daily placebo
Placebo comparator for daily aspirin therapy
Acute placebo
Placebo comparator for acute aspirin therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Hypertension during screening: SBP\>139 or DBP\>89
3. Those who are taking medications that may be expected to blunt the physiologic response to a treadmill exercise test (e.g. beta blockers)
4. Prescription medication with known side effect of impaired thermoregulation
5. Positive pregnancy test at any time during the study
6. Resting ECG with clinical presentation suggesting coronary heart disease (e.g. pathologic Q wave)
7. Known history of gastrointestinal disease or disorder i.e. diverticulitis which creates a theoretical risk of the core temperature capsule becoming lodged in the digestive tract
8. Medications and supplements known to alter endothelial function (e.g. arginine, omega 3 fatty acids, NSAIDS, tobacco products. This exclusion may be disregarded for subjects willing to stop taking the supplement for the duration of the study
9. At the discretion of the study physician for any other medical condition or prescription medication
10. Known history of platelet dysfunction
11. Aspirin allergy or intolerance
18 Years
49 Years
ALL
Yes
Sponsors
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Federal Emergency Management Administration
UNKNOWN
Eyemarker Systems, Inc
INDUSTRY
Dave Hostler
OTHER
Responsible Party
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Dave Hostler
Professor
Principal Investigators
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David Hostler, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh, Emergency Responder Human Performance Lab
Pittsburgh, Pennsylvania, United States
Countries
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References
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Olafiranye O, Hostler D, Winger DG, Wang L, Reis SE. Effect of aspirin on acute changes in peripheral arterial stiffness and endothelial function following exertional heat stress in firefighters: The factorial group results of the Enhanced Firefighter Rehab Trial. Vasc Med. 2015 Jun;20(3):230-6. doi: 10.1177/1358863X15571447. Epub 2015 May 4.
Hostler D, Suyama J, Guyette FX, Moore CG, Pryor RR, Khorana P, McEntire SJ, Comer D, Reis SE. A randomized controlled trial of aspirin and exertional heat stress activation of platelets in firefighters during exertion in thermal protective clothing. Prehosp Emerg Care. 2014 Jul-Sep;18(3):359-67. doi: 10.3109/10903127.2013.869644. Epub 2014 Feb 18.
Study Documents
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Document Type: Clinical Study Report
View DocumentDocument Type: Clinical Study Report
View DocumentOther Identifiers
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EMW-2008-FP-01638
Identifier Type: -
Identifier Source: org_study_id