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

Intraoperative Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891461
• Other study ID #: BS12-000835
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2013
• Last updated: August 8, 2017
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: August 2017
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Intraoperative Bleeding
• Post-operative Bleeding
• Postoperative Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
Canada	Hopital du sacre coeur de montreal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal	Baxter Healthcare Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need of transfusion post-op (yes/no, how many)		post op day 1 to 7