Thrombosis
Conditions
Keywords
Gonarthrosis, Knee prosthesis insertion, Bleeding, Undergoing a total knee prothesis surgery, knee prothesis surgery, Knee arthrosis, Thrombosis
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.
Interventions
DRUGHuman Fibrinogen and human thrombin (Evicel)
Product to be applied intraoperatively. No further administration will take place after this.
DRUGSodium Chlorure (Physiological saline)
Sterile concentration, local use.
Sponsors
Clinique Mutualiste Chirurgicale de la Loire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The rate of red blood cell transfusion | Day 1, Day 3, Day 5 and at the hospitalisation end |
| The hematoma size | Day 1, Day 3, Day 5 and at the hospitalisation end |
| The site incision state | Day 1, Day 3, Day 5 and at the hospitalisation end |
| The rest and movement pain | Day 1, Day 3, Day 5 and at the hospitalisation end |
| The antalgic consumption | Day 1, Day 3, Day 5 and at the hospitalisation end |
| The rate of cell saver transfusion the surgery day | Day 0 |
| Major rate or clinically significative hemorrhage. | Between Day 1 and the hospitalisation end |
| Infectious complications. | Between Day 1 and the hospitalisation end |
| The rate of SUSARs. | Between Day 1 and the end of the study (6 months post-operative) |
| The rate ot thrombotics events. | Between Day 1 and the hospitalisation end |
| 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 |
Countries
France
Contacts
Primary ContactDenis BAYLOT, MD-PhD
Outcome results
None listed