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

Clinique Mutualiste Chirurgicale de la Loire116 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

116

Conditions

Thrombosis

Interventions

Human Fibrinogen and human thrombin (Evicel)DRUG

Product to be applied intraoperatively. No further administration will take place after this.

Sodium Chlorure (Physiological saline)DRUG

Sterile concentration, local use.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

Outcomes

Primary Outcomes

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