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

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ClinicalTrials.gov Identifier: NCT01066923
Recruitment Status : Completed
First Posted : February 10, 2010
Results First Posted : August 17, 2016
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
Federal Emergency Management Administration
Eyemarker Systems, Inc
Information provided by (Responsible Party):
Dave Hostler, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Heat Stress Disorders
Interventions Drug: Daily aspirin (ASA)
Other: Active cooling
Drug: Acute aspirin (ASA)
Other: Passive cooling
Drug: Daily placebo
Drug: Acute placebo
Enrollment 124
Recruitment Details  
Pre-assignment Details Active Cooling Arm not completed - insufficient number of subjects were recruited to complete these arms of the trial, and the Passive Cooling arms were the only ones conducted.
Arm/Group Title Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Hide Arm/Group Description

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Passive cooling: Removing protective garments for passive cooling following exercise

Acute placebo: Placebo comparator for acute aspirin therapy

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

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

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

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

Acute placebo: Placebo comparator for acute aspirin therapy

Period Title: Overall Study
Started 28 32 33 31
Platelet Closure Time 25 29 25 23
Vascular Function 13 14 12 13
Activation of Coagulation 0 0 0 0
Retinal Imaging 0 0 0 0
Completed 25 29 25 23
Not Completed 3 3 8 8
Reason Not Completed
Withdrawal by Subject             3             3             8             8
Arm/Group Title 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
Hide Arm/Group Description

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Passive cooling: Removing protective garments for passive cooling following exercise

Acute placebo: Placebo comparator for acute aspirin therapy

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

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

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

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

Acute placebo: Placebo comparator for acute aspirin therapy

Total of all reporting groups
Overall Number of Baseline Participants 25 29 25 23 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 29 participants 25 participants 23 participants 102 participants
33.2  (10.1) 29.3  (8.6) 30.5  (8.5) 34.5  (9.3) 31.8  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 29 participants 25 participants 23 participants 102 participants
Female
1
   4.0%
3
  10.3%
4
  16.0%
0
   0.0%
8
   7.8%
Male
24
  96.0%
26
  89.7%
21
  84.0%
23
 100.0%
94
  92.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 29 participants 25 participants 23 participants 102 participants
25 29 25 23 102
1.Primary Outcome
Title Platelet Closure Time
Hide Description [Not Specified]
Time Frame 0, 30, 60, and 90 minutes post exercise
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Hide Arm/Group Description:

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Passive cooling: Removing protective garments for passive cooling following exercise

Acute placebo: Placebo comparator for acute aspirin therapy

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

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

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

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

Acute placebo: Placebo comparator for acute aspirin therapy

Overall Number of Participants Analyzed 25 29 25 23
Median (Inter-Quartile Range)
Unit of Measure: seconds
Immediate post exercise
275.5
(62 to 300)
207
(55 to 300)
95
(71 to 182)
90
(58 to 201)
30 minutes post
300
(300 to 300)
300
(150 to 300)
300
(110 to 300)
105
(80 to 120)
60 minutes post
300
(300 to 300)
300
(120 to 300)
300
(125 to 300)
105
(80 to 120)
90 minutes post
300
(300 to 300)
275
(120 to 300)
300
(150 to 300)
105
(80 to 120)
2.Primary Outcome
Title Vascular Function Measured by Peripheral Arterial Tonometry
Hide Description Reactive Hyperemia Index
Time Frame Baseline, 30, 60, and 90 minutes post exercise
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Hide Arm/Group Description:

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Passive cooling: Removing protective garments for passive cooling following exercise

Acute placebo: Placebo comparator for acute aspirin therapy

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

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

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

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

Acute placebo: Placebo comparator for acute aspirin therapy

Overall Number of Participants Analyzed 13 14 12 13
Mean (Standard Deviation)
Unit of Measure: ratio (Reactive Hyperemia Index)
Baseline 1.89  (0.38) 1.77  (0.51) 2.16  (0.74) 1.72  (0.34)
30 minutes post 1.97  (0.56) 1.77  (0.38) 1.77  (0.71) 1.73  (0.30)
60 minutes post 2.18  (0.48) 1.92  (0.48) 1.56  (0.68) 1.83  (0.40)
90 minutes post 2.09  (0.31) 1.98  (0.45) 1.91  (0.66) 1.98  (0.51)
3.Secondary Outcome
Title Activation of Coagulation
Hide Description This measure was not collected. Equipment was not available.
Time Frame 0, 30, 60, and 90 minutes post exercise
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This measure was not collected. Equipment was not available.
Arm/Group Title Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Hide Arm/Group Description:

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Passive cooling: Removing protective garments for passive cooling following exercise

Acute placebo: Placebo comparator for acute aspirin therapy

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

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

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

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

Acute placebo: Placebo comparator for acute aspirin therapy

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Hyperthermia and Hemoconcentration Identified by Retinal Imaging
Hide Description This measure was not collected. Equipment was not available.
Time Frame 0, 30, 60, and 90 minutes post exercise
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This measure was not collected. Equipment was not available.
Arm/Group Title Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Hide Arm/Group Description:

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Passive cooling: Removing protective garments for passive cooling following exercise

Acute placebo: Placebo comparator for acute aspirin therapy

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

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

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

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

Acute placebo: Placebo comparator for acute aspirin therapy

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Hide Arm/Group Description

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

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

Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol

Passive cooling: Removing protective garments for passive cooling following exercise

Acute placebo: Placebo comparator for acute aspirin therapy

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

Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

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

Passive cooling: Removing protective garments for passive cooling following exercise

Daily placebo: Placebo comparator for daily aspirin therapy

Acute placebo: Placebo comparator for acute aspirin therapy

All-Cause Mortality
Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/29 (0.00%)   0/25 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Daily ASA, Passive Cool, Acute ASA Daily ASA, Passive Cool, Acute Placebo Daily Placebo, Passive Cool, Acute ASA Daily Placebo, Passive Cool, Acute Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/29 (0.00%)   0/25 (0.00%)   0/23 (0.00%) 
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clifton Callaway
Organization: University of Pittsburgh
Phone: 412-647-3078
Responsible Party: Dave Hostler, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01066923     History of Changes
Other Study ID Numbers: EMW-2008-FP-01638
First Submitted: February 5, 2010
First Posted: February 10, 2010
Results First Submitted: March 18, 2016
Results First Posted: August 17, 2016
Last Update Posted: November 13, 2017