Clinical Trial: Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 R
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 Summary:
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:
-
Efficacy (during hospital stay)
- Pre-op and post-op Hg (> 100; 80-100; <80)
- Hemovac blood drainage (ml)
- Per operative bleeding (ml)
-
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)
Sponsor: Hopital du Sacre-Coeur de Montreal
Current Primary Outcome: Need of transfusion post-op (yes/no, how many) [ Time Frame: post op day 1 to 7 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hopital du Sacre-Coeur de Montreal
Dates:
Date Received: June 25, 2013
Date Started: January 2012
Date Completion: January 2017
Last Updated: February 18, 2016
Last Verified: February 2016
