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

Study Overview
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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.

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

Official Title
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Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: Human Fibrinogen and human thrombin (Evicel)
* Drug: Sodium Chlorure (Physiological saline)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evicel<br> | Drug: Human Fibrinogen and human thrombin (Evicel)<br>* Product to be applied intraoperatively. No further administration will take place after this.<br>* Other names: Evicel;|
| Placebo Comparator: Placebo<br> | Drug: Sodium Chlorure (Physiological saline)<br>* Sterile concentration, local use.<br>* Other names: Physiological saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of cell saver transfusion the surgery day |  | Day 0 | 
| The rate of red blood cell transfusion |  | Day 1, Day 3, Day 5 and at the hospitalisation end | 
| The hematoma size |  | Day 1, Day 3, Day 5 and at the hospitalisation end | 
| 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 functional recovering index |  | Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative | 
| Major rate or clinically significative hemorrhage. |  | Between Day 1 and the hospitalisation end | 
| Infectious complications. |  | Between Day 1 and the hospitalisation end | 
| The rate of SUSARs. |  | Between Day 1 and the end of the study (6 months post-operative) | 
| The rate ot thrombotics events. |  | Between Day 1 and the hospitalisation end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonarthrosis, Knee prosthesis insertion, Bleeding, Undergoing a total knee prothesis surgery, knee prothesis surgery, Knee arthrosis, Thrombosis