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

Primary Purpose

Thrombosis

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Human Fibrinogen and human thrombin (Evicel)
Sodium Chlorure (Physiological saline)
Sponsored by
Clinique Mutualiste Chirurgicale de la Loire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thrombosis focused on measuring Gonarthrosis, Knee prosthesis insertion, Bleeding, Undergoing a total knee prothesis surgery, knee prothesis surgery, Knee arthrosis, Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Evicel

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The rate of cell saver transfusion the surgery day
The rate of red blood cell transfusion
The hematoma size
The site incision state
The rest and movement pain
The antalgic consumption
The functional recovering index
Major rate or clinically significative hemorrhage.
Infectious complications.
The rate of SUSARs.
The rate ot thrombotics events.

Full Information

First Posted
September 18, 2009
Last Updated
April 24, 2012
Sponsor
Clinique Mutualiste Chirurgicale de la Loire
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1. Study Identification

Unique Protocol Identification Number
NCT00983112
Brief Title
Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery
Official Title
Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Mutualiste Chirurgicale de la Loire

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
Gonarthrosis, Knee prosthesis insertion, Bleeding, Undergoing a total knee prothesis surgery, knee prothesis surgery, Knee arthrosis, Thrombosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evicel
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Human Fibrinogen and human thrombin (Evicel)
Other Intervention Name(s)
Evicel
Intervention Description
Product to be applied intraoperatively. No further administration will take place after this.
Intervention Type
Drug
Intervention Name(s)
Sodium Chlorure (Physiological saline)
Other Intervention Name(s)
Physiological saline
Intervention Description
Sterile concentration, local use.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The rate of cell saver transfusion the surgery day
Time Frame
Day 0
Title
The rate of red blood cell transfusion
Time Frame
Day 1, Day 3, Day 5 and at the hospitalisation end
Title
The hematoma size
Time Frame
Day 1, Day 3, Day 5 and at the hospitalisation end
Title
The site incision state
Time Frame
Day 1, Day 3, Day 5 and at the hospitalisation end
Title
The rest and movement pain
Time Frame
Day 1, Day 3, Day 5 and at the hospitalisation end
Title
The antalgic consumption
Time Frame
Day 1, Day 3, Day 5 and at the hospitalisation end
Title
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
Title
Major rate or clinically significative hemorrhage.
Time Frame
Between Day 1 and the hospitalisation end
Title
Infectious complications.
Time Frame
Between Day 1 and the hospitalisation end
Title
The rate of SUSARs.
Time Frame
Between Day 1 and the end of the study (6 months post-operative)
Title
The rate ot thrombotics events.
Time Frame
Between Day 1 and the hospitalisation end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis BAYLOT, MD-PhD
Phone
+33(0)477828391
Email
dbaylot@mutualite-loire.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis BAYLOT, Dr
Organizational Affiliation
Clinique Mutualiste Chirurgicale
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MD-PhD
First Name & Middle Initial & Last Name & Degree
Denis BAYLOT, MD-PhD
First Name & Middle Initial & Last Name & Degree
François CHALENCON, MD-PhD
First Name & Middle Initial & Last Name & Degree
Jean-Paul PASSOT, MD-PhD

12. IPD Sharing Statement

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

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