Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
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|ClinicalTrials.gov Identifier: NCT01891461|
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intraoperative Bleeding Post-operative Bleeding||Drug: Floseal||Phase 4|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Floseal will be administered during the procedure and prior to release of the tourniquet (if used PRN during the cementing procedure (±10 minutes)) and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissue by the use of a delivery syringe. Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Preparation of Floseal requires mixing 5,000 US units of package thrombin (bovine-derived) made up to 5 milliliters of saline solution, to the Gelatin Matrix solution. In this study, 2-4 vials (15-20 mls total) will be used.
Floseal (5 milliliters) will be applied to the exposed bone in the following order: around the margins of the tibia, the femur (anterior surface, intercondylar notch, exposed medial and lateral condyles) and around the un resurfaced portion of the patella. The other syringes (each of 5 milliliters) will then be applied to the supra-patellar synovium and into the medial and lateral gutters of the knee. No Floseal will be applied outside the knee joint capsule.
Other Name: Hemostatic Matrix
No Intervention: standard of care
For patients randomized to the control arm, the surgery will proceed in an otherwise identical fashion (with release of the tourniquet if used PRN during cementing procedure (±10 minutes)) and hemostasis followed by drain insertion and wound closure.
- Need of transfusion post-op (yes/no, how many) [ Time Frame: post op day 1 to 7 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01891461
|Hopital du sacre coeur de montreal|
|Montreal, Quebec, Canada, H4J 1C5|
|Principal Investigator:||Julio C Fernandes, MDMScMBAPhD||Hopital du Sacre-Coeur de Montreal|