Trial | NCT00983112  Report issue

Title

Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery
Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    116
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 Started
Sep 30
2009
Primary Completion
Sep 30
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Apr 25
2012
Estimate

Drug Human Fibrinogen and human thrombin (Evicel)

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

  • Other names: Evicel

Drug Sodium Chlorure (Physiological saline)

Sterile concentration, local use.

  • Other names: Physiological saline

Evicel Experimental

Placebo Placebo Comparator

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
No Results Posted