- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372138
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
Conditions
Intervention / Treatment
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
-
-
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Rennes, France, 35033
- Service de Chirurgie Vasculaire - Hôpital de Pontchaillou
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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
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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
|
|
perioperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of the perioperative surgical technique for injecting PRP + autologous thrombin
Time Frame: perioperative
|
|
perioperative
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Rate of occurrence of endoleaks at 1 month and types of endoleaks,
Time Frame: 1 month
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1 month
|
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Time to onset of endoleaks,
Time Frame: 1 month
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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
|
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< 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFSSAPS TC211
- LOC/05-04 (OTHER: Rennes University Hospital)
- CIC0203/057
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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