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

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinique Mutualiste Chirurgicale de la Loire
• Treatments: Thrombin

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