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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) ;


Study Design


Related Conditions & MeSH terms


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

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