NCT01891461

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Conditions

• Intraoperative Bleeding
• Post-operative Bleeding

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-07-03
• Last updated: 2017-08-09

Locations

1 site across 1 country: Canada