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

This study has been completed.
Sponsor:
Collaborator:
Federal Emergency Management Agency
Information provided by (Responsible Party):
Gavin Horn, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01276691
First received: January 10, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Cardiovascular Risk Factor
C.Medical Procedure; Vascular, Functional or Late
Hemostatic Balance
Drug: 81 mg enteric coated aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting

Resource links provided by NLM:


Further study details as provided by University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • Vascular function [ Time Frame: Less than 60 minutes before initiating firefighting activity ] [ Designated as safety issue: No ]
    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 [ Time Frame: Less than 60 minutes before initiating firefighting activity ] [ Designated as safety issue: No ]
    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 [ Time Frame: Less than 60 minutes before initiating firefighting activity ] [ Designated as safety issue: No ]
    CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin

  • Vascular function [ Time Frame: Less than 60 minutes after completing 20 minutes of firefighting activity ] [ Designated as safety issue: No ]
    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 [ Time Frame: Less than 60 minutes after completing 20 minutes of firefighting activity ] [ Designated as safety issue: No ]
    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 [ Time Frame: Less than 60 minutes after completing 20 minutes of firefighting activity ] [ Designated as safety issue: No ]
    CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin


Enrollment: 24
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: aspirin

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276691

Locations
United States, Illinois
Illinois Fire Service Institute
Champaign, Illinois, United States, 61820
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Federal Emergency Management Agency
Investigators
Principal Investigator: Gavin P Horn, PhD University of Illinois Urbana-Champaign
  More Information

Additional Information:
No publications provided

Responsible Party: Gavin Horn, Senior Research Scientist, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01276691     History of Changes
Other Study ID Numbers: AsprinFire2011
Study First Received: January 10, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Urbana-Champaign:
Vascular function
Inflammation
Oxidative stress
Hemostatic balance
Aspirin
Firefighting

Additional relevant MeSH terms:
Aspirin
Hemostatics
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Coagulants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014