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

Clinique Mutualiste Chirurgicale de la Loire

Status and phase

Unknown

Phase 4

Conditions

Thrombosis

Treatments

Drug: Sodium Chlorure (Physiological saline)

Drug: Human Fibrinogen and human thrombin (Evicel)

Study type

Interventional

Funder types

Other

Identifiers

NCT00983112

2009-003

2009-010802-12

Details and patient eligibility

About

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.

Full description

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

Enrollment

116 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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