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

NCT01066923 | Completed Results

• 1 other identifier: EMW-2008-FP-01638
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Heat Stress Disorders

Keywords

firefighter; heat stress; platelet activation; aspirin

Outcome Measures

Primary Outcomes (2)

• Platelet Closure Time

  0, 30, 60, and 90 minutes post exercise

• Vascular Function Measured by Peripheral Arterial Tonometry

  Reactive Hyperemia Index

  Baseline, 30, 60, and 90 minutes post exercise

Secondary Outcomes (2)

• Activation of Coagulation

  0, 30, 60, and 90 minutes post exercise

• Hyperthermia and Hemoconcentration Identified by Retinal Imaging

  0, 30, 60, and 90 minutes post exercise

Study Arms (8)

Daily ASA, Active cool, Acute ASA

EXPERIMENTAL

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

Drug: Daily aspirin (ASA); Other: Active cooling; Drug: Acute aspirin (ASA)

Daily ASA, Active cool, Acute placebo

EXPERIMENTAL

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

Drug: Daily aspirin (ASA); Other: Active cooling; Drug: Acute placebo

Daily ASA, Passive cool, Acute ASA

EXPERIMENTAL

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

Drug: Daily aspirin (ASA); Drug: Acute aspirin (ASA); Other: Passive cooling

Daily ASA, Passive cool, Acute placebo

EXPERIMENTAL

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

Drug: Daily aspirin (ASA); Other: Passive cooling; Drug: Acute placebo

Daily placebo, active cool, Acute ASA

EXPERIMENTAL

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

Other: Active cooling; Drug: Acute aspirin (ASA); Drug: Daily placebo

Daily placebo, active cool, Acute placebo

EXPERIMENTAL

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

Other: Active cooling; Drug: Daily placebo; Drug: Acute placebo

Daily placebo, Passive cool, Acute ASA

EXPERIMENTAL

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

Drug: Acute aspirin (ASA); Other: Passive cooling; Drug: Daily placebo

Daily placebo, Passive cool, Acute placebo

PLACEBO COMPARATOR

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

Other: Passive cooling; Drug: Daily placebo; Drug: Acute placebo

Interventions

Daily aspirin (ASA) DRUG

Two weeks 82 mg aspirin taken orally prior to exercise protocol

Daily ASA, Active cool, Acute ASA; Daily ASA, Active cool, Acute placebo; Daily ASA, Passive cool, Acute ASA; Daily ASA, Passive cool, Acute placebo

Active cooling OTHER

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

Daily ASA, Active cool, Acute ASA; Daily ASA, Active cool, Acute placebo; Daily placebo, active cool, Acute ASA; Daily placebo, active cool, Acute placebo

Acute aspirin (ASA) DRUG

325 mg chewable aspirin administered immediately following exercise

Daily ASA, Active cool, Acute ASA; Daily ASA, Passive cool, Acute ASA; Daily placebo, Passive cool, Acute ASA; Daily placebo, active cool, Acute ASA

Passive cooling OTHER

Removing protective garments for passive cooling following exercise

Daily ASA, Passive cool, Acute ASA; Daily ASA, Passive cool, Acute placebo; Daily placebo, Passive cool, Acute ASA; Daily placebo, Passive cool, Acute placebo

Daily placebo DRUG

Placebo comparator for daily aspirin therapy

Daily placebo, Passive cool, Acute ASA; Daily placebo, Passive cool, Acute placebo; Daily placebo, active cool, Acute ASA; Daily placebo, active cool, Acute placebo

Acute placebo DRUG

Placebo comparator for acute aspirin therapy

Daily ASA, Active cool, Acute placebo; Daily ASA, Passive cool, Acute placebo; Daily placebo, Passive cool, Acute placebo; Daily placebo, active cool, Acute placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Apparently healthy males and females aged 18-49 years

You may not qualify if:

• 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
• At the discretion of the study physician for any other medical condition or prescription medication
• Known history of platelet dysfunction
• Aspirin allergy or intolerance

Sponsors & Collaborators

• Dave Hostler: lead
• Federal Emergency Management Administration: collaborator
• Eyemarker Systems, Inc: collaborator

Study Sites (1)

University of Pittsburgh, Emergency Responder Human Performance Lab

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 25939657 RESULT

• 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.

  PMID: 24548114 RESULT

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Detailed results at Olafiranye et al. (2015) Vascular Medicine 20:230-236 and at Hostler et al. (2014) Prehospital Emergency Care 18: 359-367 These papers are linked in the Reference Section

Results Point of Contact

• Title: Clifton Callaway
• Organization: University of Pittsburgh

callawaycw@upmc.edu

412-647-3078

Study Officials

• David Hostler, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 10, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 13, 2017
• Results First Posted: August 17, 2016

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)