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

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

The purpose of this study is to compare Floseal to our standard of care (SOC) to decrease intraoperative and immediate post-operative bleeding.

Study Overview

• Status: Completed
• Conditions: Intraoperative Bleeding; Post-operative Bleeding
• Intervention / Treatment: Drug: Floseal

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Du Sacre Coeur de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need of transfusion post-op (yes/no, how many)	post op day 1 to 7

Collaborators and Investigators

• Sponsor: Hopital du Sacre-Coeur de Montreal
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Julio C Fernandes, MDMScMBAPhD, Hôpital du Sacré-Coeur de Montreal

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (ESTIMATE): July 3, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: total knee arthroplasty; post-operative bleeding; floseal
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: BS12-000835