Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 5, 2010
First Posted Date  ICMJE February 10, 2010
Results First Submitted Date  ICMJE March 18, 2016
Results First Posted Date  ICMJE August 17, 2016
Last Update Posted Date November 13, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
  • Platelet Closure Time [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
  • Vascular Function Measured by Peripheral Arterial Tonometry [ Time Frame: Baseline, 30, 60, and 90 minutes post exercise ]
    Reactive Hyperemia Index
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2010)
Platelet Closure Time [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
  • Activation of Coagulation [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
    This measure was not collected. Equipment was not available.
  • Hyperthermia and Hemoconcentration Identified by Retinal Imaging [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
    This measure was not collected. Equipment was not available.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2010)
  • Vascular function measured by peripheral arterial tonometry [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
  • Activation of Coagulation [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
  • Hyperthermia and Hemoconcentration Identified by Retinal Imaging [ Time Frame: 0, 30, 60, and 90 minutes post exercise ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation
Official Title  ICMJE Enhanced Firefighter Rehab Trial: Aspirin Versus Placebo
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Heat Stress Disorders
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Daily ASA, Active cool, Acute ASA
    Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, aspirin immediately post exercise
    Interventions:
    • Drug: Daily aspirin (ASA)
    • Other: Active cooling
    • Drug: Acute aspirin (ASA)
  • Experimental: Daily ASA, Active cool, Acute placebo
    Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, placebo immediately post exercise
    Interventions:
    • Drug: Daily aspirin (ASA)
    • Other: Active cooling
    • Drug: Acute placebo
  • Experimental: Daily ASA, Passive cool, Acute ASA
    Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise
    Interventions:
    • Drug: Daily aspirin (ASA)
    • Drug: Acute aspirin (ASA)
    • Other: Passive cooling
  • Experimental: Daily ASA, Passive cool, Acute placebo
    Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise
    Interventions:
    • Drug: Daily aspirin (ASA)
    • Other: Passive cooling
    • Drug: Acute placebo
  • Experimental: Daily placebo, active cool, Acute ASA
    Two weeks of daily placebo prior to exercise, active cooling following exercise, aspirin immediately post exercise
    Interventions:
    • Other: Active cooling
    • Drug: Acute aspirin (ASA)
    • Drug: Daily placebo
  • Experimental: Daily placebo, active cool, Acute placebo
    Two weeks of daily placebo prior to exercise, active cooling following exercise, placebo immediately post exercise
    Interventions:
    • Other: Active cooling
    • Drug: Daily placebo
    • Drug: Acute placebo
  • Experimental: Daily placebo, Passive cool, Acute ASA
    Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise
    Interventions:
    • Drug: Acute aspirin (ASA)
    • Other: Passive cooling
    • Drug: Daily placebo
  • Placebo Comparator: Daily placebo, Passive cool, Acute placebo
    Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise
    Interventions:
    • Other: Passive cooling
    • Drug: Daily placebo
    • Drug: Acute placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
124
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2010)
160
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01066923
Other Study ID Numbers  ICMJE EMW-2008-FP-01638
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dave Hostler, University of Pittsburgh
Study Sponsor  ICMJE Dave Hostler
Collaborators  ICMJE
  • Federal Emergency Management Administration
  • Eyemarker Systems, Inc
Investigators  ICMJE
Principal Investigator: David Hostler, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP