Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT01891461
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 :
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:
NCT01891461
Study Brief:
Protocol Section:
NCT01891461