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

This study has been terminated.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00372138
First received: September 5, 2006
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysms
 Procedure: PRP + autologous thrombin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Endoleaks Using Autologous Platelet Gel During Endovascular Procedures on Unruptured Abdominal Aortic Aneurysms: Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture. [ Time Frame: perioperative ] [ Designated as safety issue: Yes ]
    • 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


Secondary Outcome Measures:
  • Description of the perioperative surgical technique for injecting PRP + autologous thrombin [ Time Frame: perioperative ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]
  • Time to onset of endoleaks, [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Rate of complications related to the endovascular procedure. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • - Rate of early postoperative complications (< 30 days) [ Time Frame: < 30 days ] [ Designated as safety issue: No ]
    • 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


Enrollment: 20
Study Start Date: September 2006
Study Completion Date: July 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRP + autologous thrombin
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient eligible to endovascular treatment:

  • Any patient having an infrarenal or aortoiliac abdominal aortic aneurysm needing surgical treatment,
  • With an infrarenal neck larger than 10 mm,
  • No thrombi in the neck,
  • Calcifications of the neck smaller than 30% of the circumference.
  • The maximum diameter of the aneurysm must be at least 50 mm and/or an annual growth rate of more than 10 mm and/or if the aneurysm is symptomatic,
  • With no major tortuosity of the two iliac axes with an aortoiliac angle greater than 80°,
  • An external iliac diameter of at least 8 mm,
  • An angle between the interrenal aorta and the neck of 0-45°.
  • The patient must meet at least one of the operability criteria of the French Health Products Safety Agency (AFSSAPS)

Exclusion Criteria:

  • Patient with a hemostatic disorder, previously known or discovered during the preoperative lab work-up,
  • Patient whose arterial anatomy is incompatible with the criteria form use of a TALENT type endovascular stent graft,
  • Patient with an aneurysm whose rapid progression (risk of rupture) does not allow a radiological and scanographic assessments to be performed,
  • Patient allergic to the iodized contrast media,
  • Disease of the connective tissue (Marfan's Syndrome) or inflammatory aneurysm,
  • Patient with an aneurysm that includes the orifice of both internal iliacs,
  • Patient in whom it is essential to keep the inferior mesenteric artery permeable,
  • Patient surgically converted after failure of an endovascular technique,
  • Pregnant women,
  • Failure of stent graft insertion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372138

Locations
France
Service de Chirurgie Vasculaire - Hôpital de Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Medtronic
Investigators
Principal Investigator: Alain Cardon, MD CHU Rennes
Study Chair: Bruno Laviolle, MD CHU Rennes
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00372138     History of Changes
Other Study ID Numbers: AFSSAPS TC211, LOC/05-04, CIC0203/057
Study First Received: September 5, 2006
Last Updated: March 1, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Abdominal aortic aneurysms
Endoleaks
Prevention

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Endoleak
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Postoperative Hemorrhage
Hemorrhage
 Pathologic Processes
Postoperative Complications
Thrombin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013