Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR

Intraoperative Bleeding Clinical Trial

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 Replacement

Status Completed

Clinical Trial Summary

The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.

Clinical Trial 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 :

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) ;

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Intraoperative Bleeding
• Post-operative Bleeding
• Postoperative Hemorrhage

• NCT number: NCT01891461
• Study type: Interventional
• Source: Hopital du Sacre-Coeur de Montreal
• Status: Completed
• Phase: Phase 4
• Start date: January 2012
• Completion date: January 2017