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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor; C.Medical Procedure; Vascular, Functional or Late; Electrolyte and Fluid Balance Conditions
• Intervention / Treatment: Drug: 81 mg enteric coated aspirin

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Illinois Fire Service Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular function	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.	Less than 60 minutes before initiating firefighting activity
Hemostatic balance	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	Less than 60 minutes before initiating firefighting activity
Inflammatory and Oxidative Stress markers	CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin	Less than 60 minutes before initiating firefighting activity
Vascular function	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.	Less than 60 minutes after completing 20 minutes of firefighting activity
Hemostatic balance	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	Less than 60 minutes after completing 20 minutes of firefighting activity
Inflammatory and Oxidative Stress markers	CRP,Intercellular adhesion molecule (ICAM)-1, IL-6, MMP-9, TIMP-1, TIMP-2,8-iso-prostaglandin F2a, soluble P-selectin	Less than 60 minutes after completing 20 minutes of firefighting activity

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: Federal Emergency Management Agency
• Investigators: Principal Investigator: Gavin P Horn, PhD, University of Illinois Urbana-Champaign

Publications and helpful links

General Publications

• Smith DL, Friedman NMG, Bloom SI, Armero WL, Pence BD, Cook MD, Fernhall B, Horn GP, Woods J. Firefighting Induces Acute Inflammatory Responses that are not Relieved by Aspirin in Older Firefighters. J Occup Environ Med. 2019 Jul;61(7):617-622. doi: 10.1097/JOM.0000000000001626.
• 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.

Helpful Links

• Illinois Fire Service Institute home page

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 17, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Aspirin; Oxidative stress; Inflammation; Vascular function; Hemostatic balance; Firefighting
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: AsprinFire2011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No