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

17. juli 2020 opdateret af: Gavin Horn, University of Illinois at Urbana-Champaign

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Champaign, Illinois, Forenede Stater, 61820
        • Illinois Fire Service Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Acute, Aspirin
81 mg asprin provided 30 minutes prior to firefighting- Acute single dosage
Medicin: 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
Andre navne:
  • aspirin
Placebo komparator: Acute, Placebo
Acute single dosage of placebo provided 30 minutes prior to firefighting
Medicin: 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
Andre navne:
  • aspirin
Aktiv komparator: Chronic, Aspirin
81 mg asprin provided prior to firefighting- 14 day dosage
Medicin: 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
Andre navne:
  • aspirin
Placebo komparator: Chronic, Placebo
14 day dosage of placebo provided prior to firefighting
Medicin: 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
Andre navne:
  • aspirin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Vascular function
Tidsramme: 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.
Less than 60 minutes before initiating firefighting activity
Hemostatic balance
Tidsramme: 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
Less than 60 minutes before initiating firefighting activity
Inflammatory and Oxidative Stress markers
Tidsramme: 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
Less than 60 minutes before initiating firefighting activity
Vascular function
Tidsramme: 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.
Less than 60 minutes after completing 20 minutes of firefighting activity
Hemostatic balance
Tidsramme: 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
Less than 60 minutes after completing 20 minutes of firefighting activity
Inflammatory and Oxidative Stress markers
Tidsramme: 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
Less than 60 minutes after completing 20 minutes of firefighting activity

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Illinois at Urbana-Champaign

Samarbejdspartnere

Federal Emergency Management Agency

Efterforskere

  • Ledende efterforsker: Gavin P Horn, PhD, University of Illinois Urbana-Champaign

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2011

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

10. januar 2011

Først indsendt, der opfyldte QC-kriterier

12. januar 2011

Først opslået (Skøn)

13. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2020

Sidst verificeret

1. juli 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AsprinFire2011

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kardiovaskulær risikofaktor

Kliniske forsøg med 81 mg enteric coated aspirin

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