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

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ClinicalTrials.gov Identifier: NCT01276691
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : May 21, 2014
Sponsor:
Collaborator:
Federal Emergency Management Agency
Information provided by (Responsible Party):
Gavin Horn, University of Illinois at Urbana-Champaign

Tracking Information
First Submitted Date  ICMJE January 10, 2011
First Posted Date  ICMJE January 13, 2011
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE February 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2011)
  • Vascular function [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01276691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
Official Title  ICMJE Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Risk Factor
  • C.Medical Procedure; Vascular, Functional or Late
  • Hemostatic Balance
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Lane-Cordova AD, Ranadive SM, Yan H, Kappus RM, Sun P, Bunsawat K, Smith DL, Horn GP, Ploutz-Snyder R, Fernhall BO. Effect of Aspirin Supplementation on Hemodynamics in Older Firefighters. Med Sci Sports Exerc. 2015 Dec;47(12):2653-9. doi: 10.1249/MSS.0000000000000713.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2014)
24
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2011)
25
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01276691
Other Study ID Numbers  ICMJE AsprinFire2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gavin Horn, University of Illinois at Urbana-Champaign
Study Sponsor  ICMJE University of Illinois at Urbana-Champaign
Collaborators  ICMJE Federal Emergency Management Agency
Investigators  ICMJE
Principal Investigator: Gavin P Horn, PhD University of Illinois Urbana-Champaign
PRS Account University of Illinois at Urbana-Champaign
Verification Date May 2014

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