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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Need of transfusion post-op (yes/no, how many)
Study Overview
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 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 :
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •• 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
Arms & Interventions
Floseal
Floseal will be administered during the procedure and prior to release of the tourniquet (if used PRN during the cementing procedure (±10 minutes)) and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissue by the use of a delivery syringe. Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Preparation of Floseal requires mixing 5,000 US units of package thrombin (bovine-derived) made up to 5 milliliters of saline solution, to the Gelatin Matrix solution. In this study, 2-4 vials (15-20 mls total) will be used.
Intervention: Floseal (Drug)
Outcomes
Primary Outcomes
Need of transfusion post-op (yes/no, how many)
Time Frame: post op day 1 to 7
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Julio Fernandes
MD, MSc, MBA, PhD
Hopital du Sacre-Coeur de Montreal