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

Phase 4

• Conditions: Thrombosis
• Interventions: Drug: Sodium Chlorure (Physiological saline); Drug: Human Fibrinogen and human thrombin (Evicel)

• Registration Number: NCT00983112
• Lead Sponsor: Clinique Mutualiste Chirurgicale de la Loire

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sodium Chlorure (Physiological saline)	-
Evicel	Human Fibrinogen and human thrombin (Evicel)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France