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

NCT01891461 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2017-08-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Julio C Fernandes, MDMScMBAPhD · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01891461 on ClinicalTrials.gov