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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00983112
• Other study ID #: 2009-010802-12
• Secondary ID: 2009-003
• Status: Unknown status
• Phase: Phase 4
• First received: September 18, 2009
• Last updated: April 24, 2012
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Clinique Mutualiste Chirurgicale de la Loire
• Contact: Denis BAYLOT, MD-PhD
• Phone: +33(0)477828391
• Email: dbaylot[@]mutualite-loire.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 116
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Mutualiste Chirurgicale de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation		Day 5
Secondary	The rate of cell saver transfusion the surgery day		Day 0
Secondary	The rate of red blood cell transfusion		Day 1, Day 3, Day 5 and at the hospitalisation end
Secondary	The hematoma size		Day 1, Day 3, Day 5 and at the hospitalisation end
Secondary	The site incision state		Day 1, Day 3, Day 5 and at the hospitalisation end
Secondary	The rest and movement pain		Day 1, Day 3, Day 5 and at the hospitalisation end
Secondary	The antalgic consumption		Day 1, Day 3, Day 5 and at the hospitalisation end
Secondary	The functional recovering index		Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative
Secondary	Major rate or clinically significative hemorrhage.		Between Day 1 and the hospitalisation end
Secondary	Infectious complications.		Between Day 1 and the hospitalisation end
Secondary	The rate of SUSARs.		Between Day 1 and the end of the study (6 months post-operative)
Secondary	The rate ot thrombotics events.		Between Day 1 and the hospitalisation end