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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Evicel

Group Type EXPERIMENTAL

Human Fibrinogen and human thrombin (Evicel)

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Sodium Chlorure (Physiological saline)

Intervention Type DRUG

Sterile concentration, local use.

Interventions

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Human Fibrinogen and human thrombin (Evicel)

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

Intervention Type DRUG

Sodium Chlorure (Physiological saline)

Sterile concentration, local use.

Intervention Type DRUG

Other Intervention Names

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Evicel Physiological saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No