Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery

April 24, 2012 updated by: Clinique Mutualiste Chirurgicale de la Loire

Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery

Knee prothesis surgery is responsible of a risk of thrombosis and hemorrhage. To prevent thrombosis, patients have systematic anticoagulation after surgery which are responsible of hemorrhage. A local glue which improve local coagulation and have no impact of thrombosis can be a solution to limit hemorrhage. The purpose of this trial is to study the impact of a biological glue administration on the bleeding loss at five days after a total knee prosthesis surgery operation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42000
        • Recruiting
        • Chu Saint-Etienne
        • Contact:
          • MD-PhD
        • Principal Investigator:
          • Denis BAYLOT, MD-PhD
        • Sub-Investigator:
          • François CHALENCON, MD-PhD
        • Sub-Investigator:
          • Jean-Paul PASSOT, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient affiliated with or a beneficiary of a social security category:

    • having more than 18 years old
    • having signed the informed consent form
    • having undergone a total knee prosthesis surgery operation

Exclusion Criteria:

  • incapacity to understand the protocol
  • patient having taken anti-coagulants or clopidogrel 10 days before excepted aspirin to a dose equal or less than 160 mg/day
  • women having period so generally women having less than 50 years old
  • PT less than 60% and ACT taller than 10 sec
  • contra-indications to the drug
  • Erytropoietine treatment required before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Sodium Chlorure (Physiological saline)
Sterile concentration, local use.
Other Names:
  • Physiological saline
Experimental: Evicel
Drug: Human Fibrinogen and human thrombin (Evicel)
Product to be applied intraoperatively. No further administration will take place after this.
Other Names:
  • Evicel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation
Time Frame: Day 5
Day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate of cell saver transfusion the surgery day
Time Frame: Day 0
Day 0
The rate of red blood cell transfusion
Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end
Day 1, Day 3, Day 5 and at the hospitalisation end
The hematoma size
Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end
Day 1, Day 3, Day 5 and at the hospitalisation end
The site incision state
Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end
Day 1, Day 3, Day 5 and at the hospitalisation end
The rest and movement pain
Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end
Day 1, Day 3, Day 5 and at the hospitalisation end
The antalgic consumption
Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end
Day 1, Day 3, Day 5 and at the hospitalisation end
The functional recovering index
Time Frame: Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative
Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative
Major rate or clinically significative hemorrhage.
Time Frame: Between Day 1 and the hospitalisation end
Between Day 1 and the hospitalisation end
Infectious complications.
Time Frame: Between Day 1 and the hospitalisation end
Between Day 1 and the hospitalisation end
The rate of SUSARs.
Time Frame: Between Day 1 and the end of the study (6 months post-operative)
Between Day 1 and the end of the study (6 months post-operative)
The rate ot thrombotics events.
Time Frame: Between Day 1 and the hospitalisation end
Between Day 1 and the hospitalisation end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Mutualiste Chirurgicale de la Loire

Investigators

  • Principal Investigator: Denis BAYLOT, Dr, Clinique Mutualiste Chirurgicale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-010802-12
  • 2009-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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