An interventional study of PRP + autologous thrombin in Abdominal Aortic Aneurysms, sponsored by Rennes University Hospital. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-02.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Prevention
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 20 is below the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
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Patient eligible to endovascular treatment:
Exclusion Criteria:
simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms
Procedure: PRP + autologous thrombin
simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms
Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture.
* systemic hemodynamics (systolic, diastolic, and mean arterial pressure, before and after insertion of the endovascular stent graft, after insertion of the 2 injection catheters, and 1, 5, and 15 minutes after injection of the thrombin and PRP), * pressure inside the aneurysm 5 minutes after injection with the thrombin and PRP, * endoleaks at end of surgery, * distal embolism, colic necrosis, * rupture of the aneurysm, * prosthetic migration * plication, stenosis of the stent graft * thrombosis of the stent graft, * occlusive arterial lesion
Time frame: perioperative
Description of the perioperative surgical technique for injecting PRP + autologous thrombin
* length of the procedure, * insertion of the two injection catheters, * preparation of the platelet gel, * problem encountered during injection of the gel
Time frame: perioperative
Rate of occurrence of endoleaks at 1 month and types of endoleaks,
Time frame: 1 month
Time to onset of endoleaks,
Time frame: 1 month
Rate of complications related to the endovascular procedure.
Time frame: 1 month
- Rate of early postoperative complications (< 30 days)
* distal embolism, colic necrosis, * rupture of the aneurysm, * prosthetic migration, * plication, stenosis of the stent graft, * thrombosis of the stent graft, * occlusive arterial lesion, * reoperation and reason for reoperation
Time frame: < 30 days
The record gives a start of Sep 2006, a primary completion of Oct 2007 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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