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

Phase 4

Completed

• Conditions: Cardiovascular Risk Factor; C.Medical Procedure; Vascular, Functional or Late; Electrolyte and Fluid Balance Conditions
• Interventions: Drug: 81 mg enteric coated aspirin

• Registration Number: NCT01276691
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Study Start: 2011-02
• Primary Completion: 2011-10
• Study Completion: 2012-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acute, Aspirin	81 mg enteric coated aspirin	81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage
Acute, Placebo	81 mg enteric coated aspirin	Acute single dosage of placebo provided 30 minutes prior to firefighting
Chronic, Aspirin	81 mg enteric coated aspirin	81 mg asprin provided prior to firefighting- 14 day dosage
Chronic, Placebo	81 mg enteric coated aspirin	14 day dosage of placebo provided prior to firefighting

Primary Outcome Measures

Name	Time	Method
Inflammatory and Oxidative Stress markers	Less than 60 minutes after completing 20 minutes of firefighting activity	CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin
Hemostatic balance	Less than 60 minutes after completing 20 minutes of firefighting activity	Blood samples will be collected by a trained phlebotomist from the antecubital vein directly into vacutainers with little or no stasis using a 21-gauge needle. Samples will be used to quantify platetlet number and function, fibrinogen, prothrombin and partial thromboplastin time, t-PA and PAI-1 activities and antigen
Vascular function	Less than 60 minutes after completing 20 minutes of firefighting activity	Vascular function will be assessed via pulse wave analysis, pulse wave velocity, carotid artery compliance, beta stiffness index, forearm rsistance artery vasodilatory capacity, and brachial artery blood flow.

Trial Locations

Locations (1)

Illinois Fire Service Institute; 🇺🇸 Champaign, Illinois, United States