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A Prospective, Randomized Study to Compare the Addition of Granules of Gelatine + Thrombin to Our Standard of Care (SOC) to Control Post Operative Bleeding in Total Knee Replacement
The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.
A prospective randomized single-blind clinical trial will be conducted at the Hôpital du Sacré-Coeur de Montréal and Hôpital Jean-Talon. All patients admitted for total knee arthroplasty (TKA) between January 2012 and September 2013 Outcome variable: Patient receiving Floseal or SOC Variables under study: Primary end point: Need of transfusion post-op (yes/no, how many) Patient will be transfused if : Hg \< 80 g/L plus if patient is symptomatic: orthostatic hypotension, tachycardia (pulse\> 100/min, hypotension (\< 90/60), hx : CVA, CAD) Secondary end point: 1. Efficacy (during hospital stay) * Pre-op and post-op Hg (\> 100; 80-100; \<80) * Hemovac blood drainage (ml) * Per operative bleeding (ml) 2. Safety (Follow up: 6wks, 6 ms, 12 ms, 24 ms) * Post-op complications: infection, pain, oedema, allergic reaction. * Functional outcomes: Knee Society Score (KSS), Western Ontario and McMaster Universities questionnaire (WOMAC), International knee documentation committee form (IKDC)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Hopital du sacre coeur de montreal
Montreal, Quebec, Canada
Start Date
January 1, 2012
Primary Completion Date
January 1, 2017
Completion Date
January 1, 2017
Last Updated
August 9, 2017
132
ACTUAL participants
Floseal
DRUG
Lead Sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborators
NCT06450834
NCT05900037
Data Source & Attribution
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