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

Primary Purpose

Heat Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily aspirin (ASA)
Active cooling
Acute aspirin (ASA)
Passive cooling
Daily placebo
Acute placebo
Sponsored by
Dave Hostler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heat Stress Disorders focused on measuring firefighter, heat stress, platelet activation, aspirin

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Apparently healthy males and females aged 18-49 years

Exclusion Criteria:

  1. History of heart disease, vascular disease, or sudden death including prior MI, coronary revascularization, congenital heart disease or history of stroke
  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

Sites / Locations

  • University of Pittsburgh, Emergency Responder Human Performance Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Daily ASA, Active cool, Acute ASA

Daily ASA, Active cool, Acute placebo

Daily ASA, Passive cool, Acute ASA

Daily ASA, Passive cool, Acute placebo

Daily placebo, active cool, Acute ASA

Daily placebo, active cool, Acute placebo

Daily placebo, Passive cool, Acute ASA

Daily placebo, Passive cool, Acute placebo

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Platelet Closure Time
Vascular Function Measured by Peripheral Arterial Tonometry
Reactive Hyperemia Index

Secondary Outcome Measures

Activation of Coagulation
This measure was not collected. Equipment was not available.
Hyperthermia and Hemoconcentration Identified by Retinal Imaging
This measure was not collected. Equipment was not available.

Full Information

First Posted
February 5, 2010
Last Updated
October 10, 2017
Sponsor
Dave Hostler
Collaborators
Federal Emergency Management Administration, Eyemarker Systems, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01066923
Brief Title
Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation
Acronym
EFFoRT
Official Title
Enhanced Firefighter Rehab Trial: Aspirin Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dave Hostler
Collaborators
Federal Emergency Management Administration, Eyemarker Systems, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress Disorders
Keywords
firefighter, heat stress, platelet activation, aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily ASA, Active cool, Acute ASA
Arm Type
Experimental
Arm Description
Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, aspirin immediately post exercise
Arm Title
Daily ASA, Active cool, Acute placebo
Arm Type
Experimental
Arm Description
Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, placebo immediately post exercise
Arm Title
Daily ASA, Passive cool, Acute ASA
Arm Type
Experimental
Arm Description
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Arm Title
Daily ASA, Passive cool, Acute placebo
Arm Type
Experimental
Arm Description
Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
Arm Title
Daily placebo, active cool, Acute ASA
Arm Type
Experimental
Arm Description
Two weeks of daily placebo prior to exercise, active cooling following exercise, aspirin immediately post exercise
Arm Title
Daily placebo, active cool, Acute placebo
Arm Type
Experimental
Arm Description
Two weeks of daily placebo prior to exercise, active cooling following exercise, placebo immediately post exercise
Arm Title
Daily placebo, Passive cool, Acute ASA
Arm Type
Experimental
Arm Description
Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
Arm Title
Daily placebo, Passive cool, Acute placebo
Arm Type
Placebo Comparator
Arm Description
Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
Intervention Type
Drug
Intervention Name(s)
Daily aspirin (ASA)
Intervention Description
Two weeks 82 mg aspirin taken orally prior to exercise protocol
Intervention Type
Other
Intervention Name(s)
Active cooling
Intervention Description
Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water
Intervention Type
Drug
Intervention Name(s)
Acute aspirin (ASA)
Intervention Description
325 mg chewable aspirin administered immediately following exercise
Intervention Type
Other
Intervention Name(s)
Passive cooling
Intervention Description
Removing protective garments for passive cooling following exercise
Intervention Type
Drug
Intervention Name(s)
Daily placebo
Intervention Description
Placebo comparator for daily aspirin therapy
Intervention Type
Drug
Intervention Name(s)
Acute placebo
Intervention Description
Placebo comparator for acute aspirin therapy
Primary Outcome Measure Information:
Title
Platelet Closure Time
Time Frame
0, 30, 60, and 90 minutes post exercise
Title
Vascular Function Measured by Peripheral Arterial Tonometry
Description
Reactive Hyperemia Index
Time Frame
Baseline, 30, 60, and 90 minutes post exercise
Secondary Outcome Measure Information:
Title
Activation of Coagulation
Description
This measure was not collected. Equipment was not available.
Time Frame
0, 30, 60, and 90 minutes post exercise
Title
Hyperthermia and Hemoconcentration Identified by Retinal Imaging
Description
This measure was not collected. Equipment was not available.
Time Frame
0, 30, 60, and 90 minutes post exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hostler, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh, Emergency Responder Human Performance Lab
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25939657
Citation
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.
Results Reference
result
PubMed Identifier
24548114
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/25939657
Available IPD/Information Comments
Report of vascular function testing
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.ncbi.nlm.nih.gov/pubmed/24548114
Available IPD/Information Comments
Report of platelet function and physiology

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

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