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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

January 10, 2011
May 19, 2014
February 2011
October 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01276691 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiovascular Risk Factor
  • C.Medical Procedure; Vascular, Functional or Late
  • Hemostatic Balance
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: Acute, Aspirin
    81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage
    Intervention: Drug: 81 mg enteric coated aspirin
  • Placebo Comparator: Acute, Placebo
    Acute single dosage of placebo provided 30 minutes prior to firefighting
    Intervention: Drug: 81 mg enteric coated aspirin
  • Active Comparator: Chronic, Aspirin
    81 mg asprin provided prior to firefighting- 14 day dosage
    Intervention: Drug: 81 mg enteric coated aspirin
  • Placebo Comparator: Chronic, Placebo
    14 day dosage of placebo provided prior to firefighting
    Intervention: Drug: 81 mg enteric coated aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2012
October 2011   (final data collection date for primary outcome measure)

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.
Male
40 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01276691
AsprinFire2011
No
Gavin Horn, University of Illinois at Urbana-Champaign
University of Illinois at Urbana-Champaign
Federal Emergency Management Agency
Principal Investigator: Gavin P Horn, PhD University of Illinois Urbana-Champaign
University of Illinois at Urbana-Champaign
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP