Clinical trial NCT00983112: Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery
Official title: Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thrombosis
Keywords: Gonarthrosis
Knee prosthesis insertion
Bleeding
Undergoing a total knee prothesis surgery
knee prothesis surgery
Knee arthrosis
Thrombosis
Lead sponsor: Clinique Mutualiste Chirurgicale de la Loire
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility 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

Primary outcomes:
measure: Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation
timeFrame: Day 5
Secondary outcomes:
measure: The rate of cell saver transfusion the surgery day
timeFrame: Day 0
measure: The rate of red blood cell transfusion
timeFrame: Day 1, Day 3, Day 5 and at the hospitalisation end
measure: The hematoma size
timeFrame: Day 1, Day 3, Day 5 and at the hospitalisation end
measure: The site incision state
timeFrame: Day 1, Day 3, Day 5 and at the hospitalisation end
measure: The rest and movement pain
timeFrame: Day 1, Day 3, Day 5 and at the hospitalisation end
measure: The antalgic consumption
timeFrame: Day 1, Day 3, Day 5 and at the hospitalisation end
measure: The functional recovering index
timeFrame: Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative
measure: Major rate or clinically significative hemorrhage.
timeFrame: Between Day 1 and the hospitalisation end
measure: Infectious complications.
timeFrame: Between Day 1 and the hospitalisation end
measure: The rate of SUSARs.
timeFrame: Between Day 1 and the end of the study (6 months post-operative)
measure: The rate ot thrombotics events.
timeFrame: Between Day 1 and the hospitalisation end
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: Clinique Mutualiste Chirurgicale
name: Denis BAYLOT, Dr
role: PRINCIPAL_INVESTIGATOR
References: