N/A
N=124
Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation
Heat Stress Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01066923 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Platelet Closure Time — 275.5; 207; 95; 90 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Daily aspirin (ASA) (Drug); Active cooling (Other); Acute aspirin (ASA) (Drug); Passive cooling (Other); Daily placebo (Drug); Acute placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dave Hostler
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet Closure Time |
275.5; 207; 95; 90; 300; 300 | — |
| PRIMARY Vascular Function Measured by Peripheral Arterial Tonometry |
1.89; 1.77; 2.16; 1.72; 1.97; 1.77 | — |
| SECONDARY Activation of Coagulation |
— | — |
| SECONDARY Hyperthermia and Hemoconcentration Identified by Retinal Imaging |
— | — |
Summary
The purpose of this study is to determine if aspirin taken by firefighters prevents platelets from becoming sticky when body temperature rises during work in protective clothing.
Eligibility Criteria
Inclusion Criteria
- Apparently healthy males and females aged 18-49 years
Exclusion Criteria
- History of heart disease, vascular disease, or sudden death including prior MI, coronary revascularization, congenital heart disease or history of stroke
- Hypertension during screening: SBP>139 or DBP>89
- Those who are taking medications that may be expected to blunt the physiologic response to a treadmill exercise test (e.g. beta blockers)
- Prescription medication with known side effect of impaired thermoregulation
- Positive pregnancy test at any time during the study
- Resting ECG with clinical presentation suggesting coronary heart disease (e.g. pathologic Q wave)
- 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
- 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
- At the discretion of the study physician for any other medical condition or prescription medication
- Known history of platelet dysfunction
- Aspirin allergy or intolerance
Data sourced from ClinicalTrials.gov (NCT01066923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.