Clinical Trial: Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prevention of Endoleaks Using Autologous Platelet Gel During Endovascular Procedures on Unruptured Abdominal Aortic Aneurysms: Pilot Study

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Rennes University Hospital

Current Primary Outcome: Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture. [ Time Frame: perioperative ]

Original Primary Outcome: Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture.

Current Secondary Outcome:

• Description of the perioperative surgical technique for injecting PRP + autologous thrombin [ Time Frame: perioperative ]
  • length of the procedure,
  • insertion of the two injection catheters,
  • preparation of the platelet gel,
  • problem encountered during injection of the gel
• 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) [ Time Frame: < 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

Original Secondary Outcome:

• Description of the perioperative surgical technique for injecting PRP + autologous thrombin
• Rate of occurrence of endoleaks at 1 month and types of endoleaks,
• Time to onset of endoleaks,
• Rate of complications related to the endovascular procedure.

Information By: Rennes University Hospital

Dates:
Date Received: September 5, 2006
Date Started: September 2006
Date Completion:
Last Updated: March 1, 2012
Last Verified: March 2012