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

Phase 4

Completed

• Conditions: Post-operative Bleeding; Intraoperative Bleeding
• Interventions: Drug: Floseal

• Registration Number: NCT01891461
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Floseal	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.

Primary Outcome Measures

Name	Time	Method
Need of transfusion post-op (yes/no, how many)	post op day 1 to 7

Trial Locations

Locations (1)

Hopital du sacre coeur de montreal; 🇨🇦 Montreal, Quebec, Canada