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

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Completed

CT.gov ID

NCT01276691

Collaborator

Federal Emergency Management Agency (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators hypothesize that

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.
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.
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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Factor C.Medical Procedure; Vascular, Functional or Late Electrolyte and Fluid Balance Conditions	Drug: 81 mg enteric coated aspirin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acute, Aspirin 81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage	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 Other Names: aspirin
Placebo Comparator: Acute, Placebo Acute single dosage of placebo provided 30 minutes prior to firefighting	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 Other Names: aspirin
Active Comparator: Chronic, Aspirin 81 mg asprin provided prior to firefighting- 14 day dosage	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 Other Names: aspirin
Placebo Comparator: Chronic, Placebo 14 day dosage of placebo provided prior to firefighting	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 Other Names: aspirin

Outcome Measures

Primary Outcome Measures

Vascular function [Less than 60 minutes before initiating 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.
Hemostatic balance [Less than 60 minutes before initiating 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
Inflammatory and Oxidative Stress markers [Less than 60 minutes before initiating firefighting activity]
CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin
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.
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.