Clinical trial NCT01276691: Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
Official title: Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Risk Factor
C.Medical Procedure; Vascular, Functional or Late
Electrolyte and Fluid Balance Conditions
Keywords: Vascular function
Inflammation
Oxidative stress
Hemostatic balance
Aspirin
Firefighting
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Federal Emergency Management Agency
First posted: 2011-01-13
Enrollment: 24
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Vascular function
timeFrame: Less than 60 minutes before initiating firefighting activity
measure: Hemostatic balance
timeFrame: Less than 60 minutes before initiating firefighting activity
measure: Inflammatory and Oxidative Stress markers
timeFrame: Less than 60 minutes before initiating firefighting activity
measure: Vascular function
timeFrame: Less than 60 minutes after completing 20 minutes of firefighting activity
measure: Hemostatic balance
timeFrame: Less than 60 minutes after completing 20 minutes of firefighting activity
measure: Inflammatory and Oxidative Stress markers
timeFrame: Less than 60 minutes after completing 20 minutes of firefighting activity
Secondary outcomes:
Other outcomes:
Locations:
city: Champaign
country: United States
facility: Illinois Fire Service Institute
state: Illinois
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Gavin P Horn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.