Status:
COMPLETED
Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Intraoperative Bleeding
Post-operative Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.
Detailed Description
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...
Eligibility Criteria
Inclusion
- All subjects above 18 years old admitted for a TKA between January 2012 and September 2013at Hôpital du Sacré-Coeur de Montréal (HSCM) and Hôpital Jean-Talon (HJT), Montréal, Quebec, Canada.
- TKA done without the use of a tourniquet except while cementing only (±10 minutes)
- TKA done with Smith and Nephew "Genesis II" or Zimmer "NexGen" total knee replacement implants
Exclusion
- • Prior osteotomy or knee surgery within last 6-8 wks
- Active, local infection or systemic infection
- Participation in any other pharmaceutical or clinical investigation
- Bleeding disorders (Hemophilia A, Hemophilia B, Von Willebrand disease, factor VIII deficiency, Vitamin K deficiency, Thrombocytopenia (platelets \< 50 x 109 per litre)
- Patients with known allergies to materials of bovine origin
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01891461
Start Date
January 1 2012
End Date
January 1 2017
Last Update
August 9 2017
Active Locations (1)
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1
Hopital du sacre coeur de montreal
Montreal, Quebec, Canada, H4J 1C5