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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276691
• Other study ID #: AsprinFire2011
• Status: Completed
• Phase: Phase 4
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2020
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 81 mg enteric coated aspirin
81 mg enteric coated aspirin will be provided both as an acute dosage immediately prior to firefighting (1 hour pre-activity) and as a 14 day dosage prior to firefighting

Locations

Country	Name	City	State
United States	Illinois Fire Service Institute	Champaign	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Federal Emergency Management Agency

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular function	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.	Less than 60 minutes before initiating firefighting activity
Primary	Hemostatic balance	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	Less than 60 minutes before initiating firefighting activity
Primary	Inflammatory and Oxidative Stress markers	CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin	Less than 60 minutes before initiating firefighting activity
Primary	Vascular function	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.	Less than 60 minutes after completing 20 minutes of firefighting activity
Primary	Hemostatic balance	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	Less than 60 minutes after completing 20 minutes of firefighting activity
Primary	Inflammatory and Oxidative Stress markers	CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin	Less than 60 minutes after completing 20 minutes of firefighting activity

External Links

•   Illinois Fire Service Institute home page