drugset / Trial / NCT00983112

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

NCT00983112 ↗

Phase 4 Unknown 116 enrolled Clinique Mutualiste Chirurgicale de la Loire
RandomizedParallel-groupSingle-blindSupportive care

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.

Timeline

Start
2009-09
Primary completion
2012-09
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Human Fibrinogen and human thrombin Unknown — Other

Indications