Status:

UNKNOWN

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

Lead Sponsor:

Clinique Mutualiste Chirurgicale de la Loire

Conditions:

Thrombosis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2012

Estimated Enrollment :

116 Patients enrolled

Trial Details

Trial ID

NCT00983112

Start Date

September 1 2009

End Date

December 1 2012

Last Update

April 25 2012

Active Locations (1)

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Page 1 of 1 (1 locations)

1

CHU Saint-Etienne

Saint-Etienne, France, 42000