Clinical Trials Directory

Trials / Completed

CompletedNCT01066923

Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation

Enhanced Firefighter Rehab Trial: Aspirin Versus Placebo

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
124 (actual)
Sponsor
Dave Hostler · Academic / Other
Sex
All
Age
18 Years – 49 Years
Healthy volunteers
Accepted

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.

Detailed description

Firefighters have the highest rate of line-of duty death (LODD) in the United States. More than half of these LODD are cardiovascular related occurring disproportionately around fire suppression activities. In addition, shift work, lifestyle factors, and the exposures associated with fire suppression (e.g. smoke, chemicals) may predispose the firefighter to earlier onset of heart disease or cause a pro-inflammatory state leading to endothelial dysfunction. 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

Interventions

TypeNameDescription
DRUGDaily aspirin (ASA)Two weeks 82 mg aspirin taken orally prior to exercise protocol
OTHERActive coolingActive cooling to remediate heat stress following exercise by placing hands and forearms into cold water
DRUGAcute aspirin (ASA)325 mg chewable aspirin administered immediately following exercise
OTHERPassive coolingRemoving protective garments for passive cooling following exercise
DRUGDaily placeboPlacebo comparator for daily aspirin therapy
DRUGAcute placeboPlacebo comparator for acute aspirin therapy

Timeline

Start date
2010-02-01
Primary completion
2011-06-01
Completion
2011-06-01
First posted
2010-02-10
Last updated
2017-11-13
Results posted
2016-08-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01066923. Inclusion in this directory is not an endorsement.