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

Montreal Sacred Heart Hospital

Status and phase: Completed; Phase 4

Conditions: Post-operative Bleeding; Intraoperative Bleeding

Treatments: Drug: Floseal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01891461

BS12-000835

Details and patient eligibility

About

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

Full 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)

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Floseal

Experimental group

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.

Treatment:

Drug: Floseal

standard of care

No Intervention group

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.