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| Name | Class |
|---|---|
| Federal Emergency Management Administration | UNKNOWN |
| Eyemarker Systems, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily ASA, Active cool, Acute ASA | Experimental | Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, aspirin immediately post exercise |
|
| Daily ASA, Active cool, Acute placebo | Experimental | Two weeks of daily aspirin therapy prior to exercise, active cooling following exercise, placebo immediately post exercise |
|
| Daily ASA, Passive cool, Acute ASA | Experimental | Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise |
|
| Daily ASA, Passive cool, Acute placebo | Experimental | Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise |
|
| Daily placebo, active cool, Acute ASA | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily aspirin (ASA) | Drug | Two weeks 82 mg aspirin taken orally prior to exercise protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of Coagulation | This measure was not collected. Equipment was not available. | 0, 30, 60, and 90 minutes post exercise |
| Hyperthermia and Hemoconcentration Identified by Retinal Imaging |
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Inclusion Criteria:
1. Apparently healthy males and females aged 18-49 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hostler, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, Emergency Responder Human Performance Lab | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25939657 | Result | 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. | |
| 24548114 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Platelet Closure Time | Posted | Median | Inter-Quartile Range | seconds | 0, 30, 60, and 90 minutes post exercise |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clifton Callaway | University of Pittsburgh | 412-647-3078 | callawaycw@upmc.edu |
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| ID | Term |
|---|---|
| D018882 | Heat Stress Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Two weeks of daily placebo prior to exercise, active cooling following exercise, aspirin immediately post exercise |
|
| Daily placebo, active cool, Acute placebo | Experimental | Two weeks of daily placebo prior to exercise, active cooling following exercise, placebo immediately post exercise |
|
| Daily placebo, Passive cool, Acute ASA | Experimental | Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise |
|
| Daily placebo, Passive cool, Acute placebo | Placebo Comparator | Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise |
|
| Active cooling | Other | Active cooling to remediate heat stress following exercise by placing hands and forearms into cold water |
|
| Acute aspirin (ASA) | Drug | 325 mg chewable aspirin administered immediately following exercise |
|
| Passive cooling | Other | Removing protective garments for passive cooling following exercise |
|
| Daily placebo | Drug | Placebo comparator for daily aspirin therapy |
|
| Acute placebo | Drug | Placebo comparator for acute aspirin therapy |
|
This measure was not collected. Equipment was not available.
| 0, 30, 60, and 90 minutes post exercise |
| 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. |
Report of vascular function testing |
| Clinical Study Report | View IPD | Report of platelet function and physiology |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| Primary | Vascular Function Measured by Peripheral Arterial Tonometry | Reactive Hyperemia Index | Posted | Mean | Standard Deviation | ratio (Reactive Hyperemia Index) | Baseline, 30, 60, and 90 minutes post exercise |
|
|
|
| Secondary | Activation of Coagulation | This measure was not collected. Equipment was not available. | This measure was not collected. Equipment was not available. | Posted | 0, 30, 60, and 90 minutes post exercise |
|
|
| Secondary | Hyperthermia and Hemoconcentration Identified by Retinal Imaging | This measure was not collected. Equipment was not available. | This measure was not collected. Equipment was not available. | Posted | 0, 30, 60, and 90 minutes post exercise |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 29 | 0 | 29 |
| EG002 | 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 | 0 | 25 | 0 | 25 |
| EG003 | 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 | 0 | 23 | 0 | 23 |
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| 30 minutes post |
|
| 60 minutes post |
|
| 90 minutes post |
|