CompletedNot Applicable

Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.

France65 participantsStarted 2019-07-29

Plain-language summary

Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups: * Arm 1 : Patients with aortic clamping with pre-conditioning * Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during 60 days after surgery.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient \> 18 and \<85 years old
. Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,
. Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,
. Aortic aneurysmal patient with or without distal femoral circulatory assistance,
. Patient with aortic aneurysm of atheromatous or dissecting etiology,
. Woman of childbearing potential with effective contraception (estrogen-progestin or intrauterine device or tubal ligation), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
. Patient who read and understood the newsletter and signed the consent form

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

occurrence of a pulmonary complication

Timeframe: Before the 48 hours after the beginning surgery

occurrence of a kidney complication

Timeframe: During the 8 days after surgery

occurrence of a pulmonary complication

Timeframe: During the 8 days after surgery

occurrence of a pulmonary complication

Timeframe: During the 48 hours after initial extubation

Trial details

NCT IDNCT03718312

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-11

View on ClinicalTrials.gov More Aortic Aneurysm trials

Plain-language summary

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient \> 18 and \<85 years old
. Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,
. Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,
. Aortic aneurysmal patient with or without distal femoral circulatory assistance,
. Patient with aortic aneurysm of atheromatous or dissecting etiology,
. Woman of childbearing potential with effective contraception (estrogen-progestin or intrauterine device or tubal ligation), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
. Patient who read and understood the newsletter and signed the consent form

What they're measuring

occurrence of a pulmonary complication

Timeframe: Before the 48 hours after the beginning surgery

occurrence of a kidney complication

Timeframe: During the 8 days after surgery

occurrence of a pulmonary complication

Timeframe: During the 8 days after surgery

occurrence of a pulmonary complication

Timeframe: During the 48 hours after initial extubation

Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria