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

March 1, 2012 updated by: Rennes University Hospital

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

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.

Study Overview

Status

Terminated

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rennes, France, 35033
        • Service de Chirurgie Vasculaire - Hôpital de Pontchaillou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PRP + autologous thrombin
simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms
simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture.
Time Frame: perioperative
  • 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
perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
perioperative
Rate of occurrence of endoleaks at 1 month and types of endoleaks,
Time Frame: 1 month
1 month
Time to onset of endoleaks,
Time Frame: 1 month
1 month
Rate of complications related to the endovascular procedure.
Time Frame: 1 month
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
< 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Alain Cardon, MD, CHU Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

September 5, 2006

First Submitted That Met QC Criteria

September 5, 2006

First Posted (ESTIMATE)

September 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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