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

NCT00372138 | Terminated

• 3 other identifiers: AFSSAPS TC211LOC/05-04CIC0203/057
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysms

Keywords

Abdominal aortic aneurysms; Endoleaks; Prevention

Outcome Measures

Primary Outcomes (1)

• 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

  perioperative

Secondary Outcomes (5)

• Description of the perioperative surgical technique for injecting PRP + autologous thrombin

  perioperative

• Rate of occurrence of endoleaks at 1 month and types of endoleaks,

  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

Study Arms (1)

PRP + autologous thrombin

EXPERIMENTAL

simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms

Procedure: PRP + autologous thrombin

Interventions

PRP + autologous thrombin PROCEDURE

simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms

PRP + autologous thrombin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead
• Medtronic: collaborator

Study Sites (1)

Service de Chirurgie Vasculaire - Hôpital de Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Alain Cardon, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Bruno Laviolle, MD

  CHU Rennes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 6, 2006
• Study Start: September 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: July 1, 2008
• Last Updated: March 2, 2012

Record last verified: 2012-03

Locations

FR (1)