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| ID | Type | Description | Link |
|---|---|---|---|
| LOC/05-04 | Other Identifier | Rennes University Hospital | |
| CIC0203/057 |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
The main risk of aortic aneurysms is rupture that leads to a high risk of death. A preventive surgical treatment is thus needed. In order to reduce the morbidity and mortality associated with conventional surgery, an endovascular approach (insertion of an endovascular stent graft)is now widely favored. The main problem of this procedure is the occurrence of endoleaks (persistence of a communication between the aneurysm and the aorta). A new approach is proposed to prevent these endoleaks. The principle is to draw blood from the patient, separate the blood from the platelets, and reinject both platelet rich plasma (PRP) and autologous thrombin, in order to form a platelet gel (PRP + autologous thrombin). Before studying the efficacy of this technique, its safety of use and feasibility must be evaluated.
The main risk of aortic aneurysms is rupture. Onset is usually sudden, leading to the death of the patient in 80% to 90% of cases. The elective treatment of abdominal aortic aneurysms, therefore, seems to be a priority. In order to reduce the morbidity and mortality associated with conventional surgery, an endovascular approach (insertion of an endovascular stent graft using the endovascular aneurysm repair procedure) is now widely favored. The main problem, during follow-up of patients wearing an endovascular stent graft, is the occurrence of endoleaks resulting in retrograde filling of the aneurysm sac. The ideal is to prevent these endoleaks either by new developments in endovascular stent grafts or by using adjuvant therapy during the procedure. The principle is to draw blood from the patient, separate the blood from the platelets, and reinject it into two separate catheters, one with platelet rich plasma (PRP) and the other with autologous thrombin, in order to form a platelet gel (PRP + autologous thrombin). Before studying the efficacy of this technique, its safety of use and feasibility must be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP + autologous thrombin | Experimental | simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP + autologous thrombin | Procedure | simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture. |
| perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the perioperative surgical technique for injecting PRP + autologous thrombin |
| perioperative |
| Rate of occurrence of endoleaks at 1 month and types of endoleaks, |
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Inclusion Criteria:
Patient eligible to endovascular treatment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alain Cardon, MD | Rennes University Hospital | Principal Investigator |
| Bruno Laviolle, MD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Vasculaire - Hôpital de Pontchaillou | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D057867 | Endoleak |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 month |
| Time to onset of endoleaks, | 1 month |
| Rate of complications related to the endovascular procedure. | 1 month |
| - Rate of early postoperative complications (< 30 days) |
| < 30 days |
| D001018 |
| Aortic Diseases |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |