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

NCT01891461 | Completed Phase 4

• 1 other identifier: BS12-000835
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Bleeding; Post-operative Bleeding

Keywords

total knee arthroplasty; post-operative bleeding; floseal

Outcome Measures

Primary Outcomes (1)

• Need of transfusion post-op (yes/no, how many)

  post op day 1 to 7

Study Arms (2)

Floseal

EXPERIMENTAL

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

standard of care

NO INTERVENTION

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.

Interventions

Floseal DRUG

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.

Also known as: Hemostatic Matrix

Floseal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Hopital du sacre coeur de montreal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

FloSeal Matrix

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Julio C Fernandes, MDMScMBAPhD

  Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, MBA, PhD

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 3, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

CA (1)