Title

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

    N/A
  • Study Type

    Interventional
  • Study Participants

    124
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.
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.
Study Started
Feb 28
2010
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Results Posted
Aug 17
2016
Estimate
Last Update
Nov 13
2017

Drug Daily aspirin (ASA)

Two weeks 82 mg aspirin taken orally prior to exercise protocol

Other Active cooling

Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water

Drug Acute aspirin (ASA)

325 mg chewable aspirin administered immediately following exercise

Other Passive cooling

Removing protective garments for passive cooling following exercise

Drug Daily placebo

Placebo comparator for daily aspirin therapy

Drug Acute placebo

Placebo comparator for acute aspirin therapy

Daily ASA, Active cool, Acute ASA Experimental

Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, aspirin immediately post exercise

Daily ASA, Active cool, Acute placebo Experimental

Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, placebo immediately post exercise

Daily ASA, Passive cool, Acute ASA Experimental

Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise

Daily ASA, Passive cool, Acute placebo Experimental

Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise

Daily placebo, active cool, Acute ASA Experimental

Two weeks of daily placebo prior to exercise, active cooling following exercise, aspirin immediately post exercise

Daily placebo, active cool, Acute placebo Experimental

Two weeks of daily placebo prior to exercise, active cooling following exercise, placebo immediately post exercise

Daily placebo, Passive cool, Acute ASA Experimental

Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise

Daily placebo, Passive cool, Acute placebo Placebo Comparator

Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise

Criteria

Inclusion Criteria:

1. 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

Summary

Daily ASA, Passive Cool, Acute ASA

Daily ASA, Passive Cool, Acute Placebo

Daily Placebo, Passive Cool, Acute ASA

Daily Placebo, Passive Cool, Acute Placebo

All Events

Event Type Organ System Event Term

Platelet Closure Time

Daily ASA, Passive Cool, Acute ASA

30 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 300.0 to 300.0

60 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 300.0 to 300.0

90 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 300.0 to 300.0

Immediate post exercise

275.5
seconds (Median)
Inter-Quartile Range: 62.0 to 300.0

Daily ASA, Passive Cool, Acute Placebo

30 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 150.0 to 300.0

60 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 120.0 to 300.0

90 minutes post

275.0
seconds (Median)
Inter-Quartile Range: 120.0 to 300.0

Immediate post exercise

207.0
seconds (Median)
Inter-Quartile Range: 55.0 to 300.0

Daily Placebo, Passive Cool, Acute ASA

30 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 110.0 to 300.0

60 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 125.0 to 300.0

90 minutes post

300.0
seconds (Median)
Inter-Quartile Range: 150.0 to 300.0

Immediate post exercise

95.0
seconds (Median)
Inter-Quartile Range: 71.0 to 182.0

Daily Placebo, Passive Cool, Acute Placebo

30 minutes post

105.0
seconds (Median)
Inter-Quartile Range: 80.0 to 120.0

60 minutes post

105.0
seconds (Median)
Inter-Quartile Range: 80.0 to 120.0

90 minutes post

105.0
seconds (Median)
Inter-Quartile Range: 80.0 to 120.0

Immediate post exercise

90.0
seconds (Median)
Inter-Quartile Range: 58.0 to 201.0

Vascular Function Measured by Peripheral Arterial Tonometry

Reactive Hyperemia Index

Daily ASA, Passive Cool, Acute ASA

30 minutes post

1.97
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.56

60 minutes post

2.18
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.48

90 minutes post

2.09
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.31

Baseline

1.89
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.38

Daily ASA, Passive Cool, Acute Placebo

30 minutes post

1.77
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.38

60 minutes post

1.92
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.48

90 minutes post

1.98
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.45

Baseline

1.77
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.51

Daily Placebo, Passive Cool, Acute ASA

30 minutes post

1.77
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.71

60 minutes post

1.56
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.68

90 minutes post

1.91
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.66

Baseline

2.16
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.74

Daily Placebo, Passive Cool, Acute Placebo

30 minutes post

1.73
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.30

60 minutes post

1.83
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.40

90 minutes post

1.98
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.51

Baseline

1.72
ratio (Reactive Hyperemia Index) (Mean)
Standard Deviation: 0.34

Activation of Coagulation

This measure was not collected. Equipment was not available.

Daily ASA, Passive Cool, Acute ASA

Daily ASA, Passive Cool, Acute Placebo

Daily Placebo, Passive Cool, Acute ASA

Daily Placebo, Passive Cool, Acute Placebo

Hyperthermia and Hemoconcentration Identified by Retinal Imaging

This measure was not collected. Equipment was not available.

Daily ASA, Passive Cool, Acute ASA

Daily ASA, Passive Cool, Acute Placebo

Daily Placebo, Passive Cool, Acute ASA

Daily Placebo, Passive Cool, Acute Placebo

Total

102
Participants

Age, Continuous

31.8
years (Mean)
Standard Deviation: 8.6

Region of Enrollment

Sex: Female, Male

Overall Study

Daily ASA, Passive Cool, Acute ASA

Daily ASA, Passive Cool, Acute Placebo

Daily Placebo, Passive Cool, Acute ASA

Daily Placebo, Passive Cool, Acute Placebo

Drop/Withdrawal Reasons

Daily ASA, Passive Cool, Acute ASA

Daily ASA, Passive Cool, Acute Placebo

Daily Placebo, Passive Cool, Acute ASA

Daily Placebo, Passive Cool, Acute Placebo