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

Primary Purpose

Abdominal Aortic Aneurysms

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PRP + autologous thrombin

About this trial

This is an interventional prevention trial for Abdominal Aortic Aneurysms focused on measuring Abdominal aortic aneurysms, Endoleaks, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Chirurgie Vasculaire - Hôpital de Pontchaillou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP + autologous thrombin

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

- 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

Full Information

NCT ID

NCT00372138

First Posted

September 5, 2006

Last Updated

March 1, 2012

Sponsor

Rennes University Hospital

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT00372138

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Terminated

Study Start Date

September 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

Collaborators

Medtronic

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysms

Keywords

Abdominal aortic aneurysms, Endoleaks, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRP + autologous thrombin

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

PRP + autologous thrombin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

perioperative

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

Time Frame

1 month

Title

Time to onset of endoleaks,

Time Frame

1 month

Title

Rate of complications related to the endovascular procedure.

Time Frame

1 month

Title

- Rate of early postoperative complications (< 30 days)

Description

Time Frame

< 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alain Cardon, MD

Organizational Affiliation

CHU Rennes

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bruno Laviolle, MD

Organizational Affiliation

CHU Rennes

Official's Role

Study Chair

Facility Information:

Facility Name

Service de Chirurgie Vasculaire - Hôpital de Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

12. IPD Sharing Statement

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

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