Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting

University of Illinois at Urbana-Champaign

Status and phase: Completed; Phase 4

Conditions: Electrolyte and Fluid Balance Conditions; C.Medical Procedure; Vascular, Functional or Late; Cardiovascular Risk Factor

Treatments: Drug: 81 mg enteric coated aspirin

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01276691

AsprinFire2011

Details and patient eligibility

About

The investigators hypothesize that

1. an acute treatment of low-dose aspirin will lead to a) decreased resting platelet activation, platelet aggregation, and clotting potential, b) increased fibrinolytic potential following fire fighting, c) no significant effect on endothelial function or arterial stiffness versus the placebo condition.
2. chronic treatment with low-dose aspirin will lead to a) decreased resting and fire fighting induced platelet activation, platelet aggregation, clotting potential, b) increased fibrinolytic potential, and c) increased endothelial function and decreased arterial stiffness in response to live fire fighting versus the placebo condition.
3. short-term fire fighting activity will result in: a) a reduction in arterial function (reduced endothelial function, increased augmentation index and an attenuated arterial stiffness response); b) a disruption in hemostasis that is characterized by an increase in platelet number and function, an increased coagulatory potential and altered fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic inflammation, monokine chemoattractant protein, and matrix metalloproteinases.

Enrollment: 24 patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male firefighters (career and volunteer), medically cleared by home fire department.
• Ages 40 - 60
• Completion of a yearly period medical evaluation based on NFPA 1582 within the past 12 months or an evaluation by an occupational medical group through this study.

Exclusion criteria

• Over 60 or under 40 years of age.
• Not a firefighter.
• Individuals at risk for developing gastrointestinal (GI) complications while on aspirin therapy due to a combination of the following: smoking; concurrent NSAID, steroid, Clopidogrel, or Warfarin therapy; history of upper GI complications; history of renal impairment; history of elevated serum creatinine; hypertension; and cardiac failure.
• Individuals with cases of allergy or asthma, intolerance, and recurrent vascular events.
• Individuals taking statins.
• Individuals who are currently taking aspiring regularly.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

Acute, Aspirin

Active Comparator group

Description:

81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage

Treatment:

Drug: 81 mg enteric coated aspirin

Acute, Placebo

Placebo Comparator group

Description:

Acute single dosage of placebo provided 30 minutes prior to firefighting

Treatment:

Drug: 81 mg enteric coated aspirin

Chronic, Aspirin

Active Comparator group

Description:

81 mg asprin provided prior to firefighting- 14 day dosage

Treatment:

Drug: 81 mg enteric coated aspirin

Chronic, Placebo

Placebo Comparator group

Description:

14 day dosage of placebo provided prior to firefighting

Treatment:

Drug: 81 mg enteric coated aspirin