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Completed

NCT Number: NCT01276691

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.

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Key information

Conditions

Cardiovascular Risk Factor C.Medical Procedure; Vascular, Functional or Late Electrolyte and Fluid Balance Conditions Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Illinois Fire Service Institute

Champaign, Illinois, 61820, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

81 mg enteric coated aspirin

Drug

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Federal Emergency Management Agency

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 13, 2011
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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