NCT00983112

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Clinique Mutualiste Chirurgicale de la Loire · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Human Fibrinogen and human thrombin (Evicel)	Product to be applied intraoperatively. No further administration will take place after this.
DRUG	Sodium Chlorure (Physiological saline)	Sterile concentration, local use.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2009-09-23
• Last updated: 2012-04-25

Locations

1 site across 1 country: France