Abdominal Aortic AneurysmsNCT00372138
Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms
A study testing PRP + autologous thrombin in people with Abdominal Aortic Aneurysms, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms
- What is being tested?
- PRP + autologous thrombin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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)
Who cannot join
- 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,
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Vasculaire - Hôpital de Pontchaillou
Rennes, 35033
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysms
- Being tested
- PRP + autologous thrombin
- Keywords
- Abdominal aortic aneurysms, Endoleaks, Prevention
- Medical subject headings
- Aortic Aneurysm, Abdominal, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP + autologous thrombinProcedure or surgery
simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms
| Study group | Role | What they receive |
|---|---|---|
| PRP + autologous thrombin | Experimental | simultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms Receives: Procedure: PRP + autologous thrombin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: perioperative
Secondary outcomes (5)
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
Measured: perioperative
Rate of occurrence of endoleaks at 1 month and types of endoleaks,
Measured: 1 month
Time to onset of endoleaks,
Measured: 1 month
Rate of complications related to the endovascular procedure.
Measured: 1 month
- 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
Measured: < 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Alain Cardon, MD, Principal investigator, Rennes University HospitalBruno Laviolle, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372138
- Sponsor's protocol ID
- AFSSAPS TC211
- Other IDs
- LOC/05-04, CIC0203/057
- Status last verified
- Mar 2012
- First submitted
- 5 Sep 2006
- Last updated
- 2 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Endoleaks Using Autologous Platelet Gel During Endovascular Procedures on Unruptured Abdominal Aortic Aneurysms: Pilot Study
- ClinicalTrials.gov ID
- NCT00372138
- Acronym / sponsor ID
- AFSSAPS TC211
- Conditions
- Abdominal Aortic Aneurysms
- Keywords
- Abdominal aortic aneurysms, Endoleaks, Prevention
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP + autologous thrombin | Experimental | Procedure: PRP + autologous thrombinsimultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP + autologous thrombinsimultaneous perioperative PRP and autologous thrombin in the aneurysm sac, during the endovascular treatment of unruptured abdominal aortic aneurysms | Procedure or surgery | PRP + autologous thrombin |
Primary outcome
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
5 secondary outcomes
Description of the perioperative surgical technique for injecting PRP + autologous thrombin
Time frame: perioperative
Rate of occurrence of endoleaks at 1 month and types of endoleaks,
Time frame: 1 month
Time to onset of endoleaks,
Time frame: 1 month
Rate of complications related to the endovascular procedure.
Time frame: 1 month
- Rate of early postoperative complications (< 30 days)
Time frame: < 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Cardon, MD principal investigator
Rennes University Hospital
Bruno Laviolle, MD study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP + autologous thrombin in people with Abdominal Aortic Aneurysms, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the perioperative procedure for injecting PRP + autologous thrombin assessed by distal embolism, colic necrosis, aneurysm rupture. (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2012.