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

This study has been completed.
Sponsor:
Collaborators:
Federal Emergency Management Administration
Eyemarker Systems, Inc
Information provided by (Responsible Party):
Clifton W. Callaway, MD, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01066923
First received: February 5, 2010
Last updated: July 5, 2016
Last verified: July 2016
Results First Received: March 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Daily ASA, Passive Cool, Acute ASA

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

Daily ASA, Passive Cool, Acute Placebo

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

Daily Placebo, Passive Cool, Acute ASA

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

Daily Placebo, Passive Cool, Acute Placebo

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


Participant Flow:   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  
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  
Withdrawal by Subject                 3                 3                 8                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Daily ASA, Passive Cool, Acute ASA

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

Daily ASA, Passive Cool, Acute Placebo

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

Daily Placebo, Passive Cool, Acute ASA

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

Daily Placebo, Passive Cool, Acute Placebo

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 Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  25     29     25     23     102  
Age  
[units: years]
Mean (Standard Deviation)
  33.2  (10.1)     29.3  (8.6)     30.5  (8.5)     34.5  (9.3)     31.8  (8.6)  
Gender  
[units: participants]
         
Female     1     3     4     0     8  
Male     24     26     21     23     94  
Region of Enrollment  
[units: participants]
         
United States     25     29     25     23     102  



  Outcome Measures
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1.  Primary:   Platelet Closure Time   [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]

2.  Primary:   Vascular Function Measured by Peripheral Arterial Tonometry   [ Time Frame: Baseline, 30, 60, and 90 minutes post exercise ]

3.  Secondary:   Activation of Coagulation   [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Hyperthermia and Hemoconcentration Identified by Retinal Imaging   [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information
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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
e-mail: callawaycw@upmc.edu


Publications of Results:

Responsible Party: Clifton W. Callaway, MD, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01066923     History of Changes
Other Study ID Numbers: EMW-2008-FP-01638
Study First Received: February 5, 2010
Results First Received: March 18, 2016
Last Updated: July 5, 2016
Health Authority: United States: Institutional Review Board