Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Illinois at Urbana-Champaign.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Illinois at Urbana-Champaign
Collaborator:
Federal Emergency Management Agency
Information provided by:
University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01276691
First received: January 10, 2011
Last updated: March 9, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease Risk Vascular Function Hemostatic Function |
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
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Acute, Aspirin
Acute single dosage of 81 mg asprin 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
|
|
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
|
|
Active Comparator: Chronic, Aspirin
14 day dosage of 81 mg asprin 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
|
|
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
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276691
Contacts
| Contact: Gavin P Horn, PhD | 217-265-6563 | ghorn@fsi.illinois.edu |
Locations
| United States, Illinois | |
| Illinois Fire Service Institute | Recruiting |
| Champaign, Illinois, United States, 61820 | |
| Contact: Gavin P Horn, PhD 217-265-6563 ghorn@fsi.illinois.edu | |
| Principal Investigator: Gavin P Horn, PhD | |
| Sub-Investigator: Denise L Smith, PhD | |
| Sub-Investigator: Bo Fernhall, PhD | |
| Sub-Investigator: Jeffrey A Woods, PhD | |
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 P Horn, 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: | March 9, 2011 |
| 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:
|
Cardiovascular Diseases Aspirin Hemostatics Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents Coagulants |
ClinicalTrials.gov processed this record on June 18, 2013