Grant: Operating Grant
University of Manitoba
$288,152.00
Heparin AnticoaguLation to improve Outcomes in septic shock: The HALO pilot
FY 2011-12
Summary
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 most common cause of death in patients admitted with life-threatening infections is 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, a proven and inexpensive blood-thinner, may reduce improve survival in patients diagnosed 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 heparin in patients with severe infections. In this study, 70 patients with life-threatening infections will have an equal chance of receiving an intravenous infusion of heparin at 18 units/kg, or a low dose of a similar drug to prevent of blood clots while patients are immobile. The primary purpose of the study is to demonstrate that an average of 2 patients per site, per month, can be enrolled. 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 heparin is shown to improve survival in patients with severe infection, adoption of this therapy on a global scale is anticipated.
Department
Program
Operating Grant
Recipient
Location
Manitoba, Canada
Recipient Type
Academia
Type
Grant
Source
CIHR Funding Decisions Database
As published
Id
255417
Name
Zarychanski Ryan
Region
Manitoba
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Infection and Immunity
Theme2
Clinical
Prcname2
Clinical Investigation - C: Digestive, Endocrine and Excretory Systems
Projecttitle
Heparin AnticoaguLation to improve Outcomes in septic shock: The HALO pilot
Programtype2
Operating Grants
Orgnameinp2
University of Manitoba
Cihramount2
$288,152
Cihrequipment2
$0
Programname2
Operating Grant
Keyworddelim
Anticoagulation; Clinical Trial; Critical Care; Infection; Pilot Study; Randomized Controlled Trial; Sepsis
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 most common cause of death in patients admitted with life-threatening infections is 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, a proven and inexpensive blood-thinner, may reduce improve survival in patients diagnosed 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 heparin in patients with severe infections. In this study, 70 patients with life-threatening infections will have an equal chance of receiving an intravenous infusion of heparin at 18 units/kg, or a low dose of a similar drug to prevent of blood clots while patients are immobile. The primary purpose of the study is to demonstrate that an average of 2 patients per site, per month, can be enrolled. 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 heparin is shown to improve survival in patients with severe infection, adoption of this therapy on a global scale is anticipated.
Competitiondate
201203
Approvedterm2
2 yrs 0 mth
Pinamesdelim
Zarychanski, Ryan; Fergusson, Dean A
Approvedterm
2 ans 0 mois
Cihrcontribution2
~ $288,152~ $0~