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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01891461
Recruitment Status : Completed
First Posted : July 3, 2013
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Julio Fernandes, Hopital du Sacre-Coeur de Montreal

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.

Condition or disease Intervention/treatment Phase
Intraoperative Bleeding Post-operative Bleeding Drug: Floseal Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Floseal

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.

Drug: Floseal
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.



Primary Outcome Measures :
  1. Need of transfusion post-op (yes/no, how many) [ Time Frame: post op day 1 to 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects above 18 years old admitted for a TKA between January 2012 and September 2013at Hôpital du Sacré-Coeur de Montréal (HSCM) and Hôpital Jean-Talon (HJT), Montréal, Quebec, Canada.

    • TKA done without the use of a tourniquet except while cementing only (±10 minutes)
    • TKA done with Smith and Nephew "Genesis II" or Zimmer "NexGen" total knee replacement implants

Exclusion Criteria:

  • • Prior osteotomy or knee surgery within last 6-8 wks

    • Active, local infection or systemic infection
    • Participation in any other pharmaceutical or clinical investigation
    • Bleeding disorders (Hemophilia A, Hemophilia B, Von Willebrand disease, factor VIII deficiency, Vitamin K deficiency, Thrombocytopenia (platelets < 50 x 109 per litre)
    • Patients with known allergies to materials of bovine origin

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Hopital du sacre coeur de montreal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Julio C Fernandes, MDMScMBAPhD Hopital du Sacre-Coeur de Montreal
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Responsible Party: Dr Julio Fernandes, MD, MSc, MBA, PhD, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT01891461    
Other Study ID Numbers: BS12-000835
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Dr Julio Fernandes, Hopital du Sacre-Coeur de Montreal:
total knee arthroplasty
post-operative bleeding
floseal
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications
Hemostatics
Coagulants