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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00983112
Recruitment Status : Unknown
Verified April 2012 by Clinique Mutualiste Chirurgicale de la Loire.
Recruitment status was:  Recruiting
First Posted : September 23, 2009
Last Update Posted : April 25, 2012
Sponsor:
Information provided by (Responsible Party):
Clinique Mutualiste Chirurgicale de la Loire

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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: Human Fibrinogen and human thrombin (Evicel) Drug: Sodium Chlorure (Physiological saline) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Impact of a Biological Glue (Evicel®) on the Peri Operative Bleeding in Total Knee Prothesis Surgery
Study Start Date : September 2009
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thrombin

Arm Intervention/treatment
Experimental: Evicel Drug: Human Fibrinogen and human thrombin (Evicel)
Product to be applied intraoperatively. No further administration will take place after this.
Other Name: Evicel

Placebo Comparator: Placebo Drug: Sodium Chlorure (Physiological saline)
Sterile concentration, local use.
Other Name: Physiological saline




Primary Outcome Measures :
  1. Study the impact of a biological glue administration on the bleeding loss at Day 5 after a total knee prosthesis surgery operation [ Time Frame: Day 5 ]

Secondary Outcome Measures :
  1. The rate of cell saver transfusion the surgery day [ Time Frame: Day 0 ]
  2. The rate of red blood cell transfusion [ Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end ]
  3. The hematoma size [ Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end ]
  4. The site incision state [ Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end ]
  5. The rest and movement pain [ Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end ]
  6. The antalgic consumption [ Time Frame: Day 1, Day 3, Day 5 and at the hospitalisation end ]
  7. The functional recovering index [ Time Frame: Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative ]
  8. Major rate or clinically significative hemorrhage. [ Time Frame: Between Day 1 and the hospitalisation end ]
  9. Infectious complications. [ Time Frame: Between Day 1 and the hospitalisation end ]
  10. The rate of SUSARs. [ Time Frame: Between Day 1 and the end of the study (6 months post-operative) ]
  11. The rate ot thrombotics events. [ Time Frame: Between Day 1 and the hospitalisation end ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983112


Contacts
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Contact: Denis BAYLOT, MD-PhD +33(0)477828391 dbaylot@mutualite-loire.com

Locations
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France
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42000
Contact: MD-PhD         
Principal Investigator: Denis BAYLOT, MD-PhD         
Sub-Investigator: François CHALENCON, MD-PhD         
Sub-Investigator: Jean-Paul PASSOT, MD-PhD         
Sponsors and Collaborators
Clinique Mutualiste Chirurgicale de la Loire
Investigators
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Principal Investigator: Denis BAYLOT, Dr Clinique Mutualiste Chirurgicale
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Responsible Party: Clinique Mutualiste Chirurgicale de la Loire
ClinicalTrials.gov Identifier: NCT00983112    
Other Study ID Numbers: 2009-010802-12
2009-003
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012
Keywords provided by Clinique Mutualiste Chirurgicale de la Loire:
Gonarthrosis
Knee prosthesis insertion
Bleeding
Undergoing a total knee prothesis surgery
knee prothesis surgery
Knee arthrosis
Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombin
Hemostatics
Coagulants