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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-003 |
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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.
The orthopaedic surgeon administers a local pulverisation of the biological glue during the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evicel | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Fibrinogen and human thrombin (Evicel) | Drug | Product to be applied intraoperatively. No further administration will take place after this. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of cell saver transfusion the surgery day | Day 0 | |
| The rate of red blood cell transfusion | Day 1, Day 3, Day 5 and at the hospitalisation end | |
| The hematoma size |
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Inclusion Criteria:
Patient affiliated with or a beneficiary of a social security category:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denis BAYLOT, MD-PhD | Contact | +33(0)477828391 | dbaylot@mutualite-loire.com |
| Name | Affiliation | Role |
|---|---|---|
| Denis BAYLOT, Dr | Clinique Mutualiste Chirurgicale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Recruiting | Saint-Etienne | 42000 | France |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 3, 2015 | |
| Reset | Jun 17, 2015 | |
| Release | Nov 10, 2015 | |
| Reset | Dec 14, 2015 | |
| Release | May 27, 2016 | |
| Reset | Jul 6, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2015 | Jun 17, 2015 | |||
| Nov 10, 2015 |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D020370 | Osteoarthritis, Knee |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010003 | Osteoarthritis |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| D013917 | Thrombin |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Sodium Chlorure (Physiological saline) | Drug | Sterile concentration, local use. |
|
|
| 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 functional recovering index | Day 1, Day 3, Day 5, at the hospitalisation end and at 1 month, 3 months and 6 months post-operative |
| 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 |
| Dec 14, 2015 |
| May 27, 2016 | Jul 6, 2016 |
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |