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Grant: Operating Grant - PA: Regional Partnership Program : Manitoba

University of Manitoba

$100,000.00

A pilot randomized controlled trial to evaluate the efficacy of unfractionated Heparin in septic shock

EF 2010-11

Résumé
Life-threatening infections account for 10% of all intensive care unit admissions and constitute the second more frequent cause of death in the ICU after heart diseases. The cause of death in patients with life-threatening infections is often multi-organ failure that is mediated by severe inflammation. Given the relationship between inflammation and blood clotting, blood-thinners (also called anticoagulants) have been used to decrease inflammation and the formation of small clots. Several lines of evidence suggest that heparin, an established and inexpensive anticoagulant, may improve clinical outcomes in patients with life-threatening infection. The primary objective of this study is to demonstrate the feasibility of enrolling patients in a large randomized controlled trial investigating unfractionated heparin (UFH) in patients with severe infections. In this study, 70 patients with life-threatening infections will be have an equal chance of receiving an intravenous infusion of UFH at 18 units/kg, or standard low dose low molecular weight heparin for the prevention of blood clots. The primary purpose of the study is to demonstrate that an average of 2 patients per site, per month, can be enrolled in to this study. Other measures of feasibility include the consent rate, the number of protocol violations that occur during the trial, and the number of dose reductions needed due to excessive anticoagulation. To study the biologic effects of heparin in patients with severe infection, specific laboratory markers will be measured and analyzed. If the feasibility of the trial is confirmed, a large randomized trial designed to tell if heparin can safely improve survival will be conducted. Given its low cost and availability, if UFH is shown to be beneficial in patients with severe infection, widespread adoption of this therapy is anticipated.
Programme
Operating Grant - PA: Regional Partnership Program : Manitoba
Emplacement
Manitoba, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
234147
Name
Zarychanski Ryan
Region
Manitoba
Country
Canada
Orgtype
Institution Paid; Research Institution
Partnername
Manitoba Health Research Council
Instname2
Infection and Immunity
Theme2
Clinical
Prcname2
Clinical Investigation - C: Digestive, Endocrine and Excretory Systems
Projecttitle
A pilot randomized controlled trial to evaluate the efficacy of unfractionated Heparin in septic shock
Programtype2
Operating Grants
Orgnameinp2
University of Manitoba
Cihramount2
$100,000
Cihrequipment2
$0
Programname2
Operating Grant - PA: Regional Partnership Program : Manitoba
Keyworddelim
Anticoagulants; Coagulation; Critical Care; Inflammation; Randomized Controlled Trials; Sepsis; Unfractionated Heparin
Abstract
Life-threatening infections account for 10% of all intensive care unit admissions and constitute the second more frequent cause of death in the ICU after heart diseases. The cause of death in patients with life-threatening infections is often multi-organ failure that is mediated by severe inflammation. Given the relationship between inflammation and blood clotting, blood-thinners (also called anticoagulants) have been used to decrease inflammation and the formation of small clots. Several lines of evidence suggest that heparin, an established and inexpensive anticoagulant, may improve clinical outcomes in patients with life-threatening infection. The primary objective of this study is to demonstrate the feasibility of enrolling patients in a large randomized controlled trial investigating unfractionated heparin (UFH) in patients with severe infections. In this study, 70 patients with life-threatening infections will be have an equal chance of receiving an intravenous infusion of UFH at 18 units/kg, or standard low dose low molecular weight heparin for the prevention of blood clots. The primary purpose of the study is to demonstrate that an average of 2 patients per site, per month, can be enrolled in to this study. Other measures of feasibility include the consent rate, the number of protocol violations that occur during the trial, and the number of dose reductions needed due to excessive anticoagulation. To study the biologic effects of heparin in patients with severe infection, specific laboratory markers will be measured and analyzed. If the feasibility of the trial is confirmed, a large randomized trial designed to tell if heparin can safely improve survival will be conducted. Given its low cost and availability, if UFH is shown to be beneficial in patients with severe infection, widespread adoption of this therapy is anticipated.
Competitiondate
201103
Approvedterm2
2 yrs 0 mth
Pinamesdelim
Zarychanski, Ryan; Fergusson, Dean A
Approvedterm
2 ans 0 mois
Cihrcontribution2
SPIR~ $100,000~ $0~