Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT01891461
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2013-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Organization:
Study Overview
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
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: