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

Primary Purpose

Intraoperative Bleeding, Post-operative Bleeding

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Floseal
Sponsored by
Hopital du Sacre-Coeur de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Bleeding focused on measuring total knee arthroplasty, post-operative bleeding, floseal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hopital du sacre coeur de montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Floseal

standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Need of transfusion post-op (yes/no, how many)

Secondary Outcome Measures

Full Information

First Posted
June 25, 2013
Last Updated
August 8, 2017
Sponsor
Hopital du Sacre-Coeur de Montreal
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01891461
Brief Title
Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR
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 Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital du Sacre-Coeur de Montreal
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Bleeding, Post-operative Bleeding
Keywords
total knee arthroplasty, post-operative bleeding, floseal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Floseal
Arm Type
Experimental
Arm Description
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.
Arm Title
standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Floseal
Other Intervention Name(s)
Hemostatic Matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Need of transfusion post-op (yes/no, how many)
Time Frame
post op day 1 to 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio C Fernandes, MDMScMBAPhD
Organizational Affiliation
Hopital du Sacre-Coeur de Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital du sacre coeur de montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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