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

NCT ID: NCT03718312

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2023-07-29

Brief 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.

Conditions

Aortic Aneurysm; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1

Patients with aortic clamping withpre-conditioning

Group Type: EXPERIMENTAL

clamping with pre-conditioning (PCl)

Intervention Type: PROCEDURE

PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period.

PCI procedure is repeated twice.

Arm 2

Patients with aortic clamping without pre-conditioning

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

clamping with pre-conditioning (PCl)

PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period.

PCI procedure is repeated twice.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patient > 18 and <85 years old

2. Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,

3. Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,

4. Aortic aneurysmal patient with or without distal femoral circulatory assistance,

5. Patient with aortic aneurysm of atheromatous or dissecting etiology,

6. 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)

7. Patient who read and understood the newsletter and signed the consent form

8. Patient affiliated with a social security scheme

Exclusion Criteria

1. Patient with aortic aneurysms requiring supra-visceral aortic clamping but not requiring visceral artery reconstruction (supra-visceral aortic clamping for renal aortic juxtaposition aorta),

2. Patient with thoraco abdominal aortic aneurysms requiring a circulatory arrest (aortic aneurysms affecting the descending thoracic aorta or the aortic arch)

3. Patient requiring emergency aortic surgery

4. Patient under treatment known as interfering with PCI (Nicorandil or oral antidiabetic agents),

5. Pregnant or lactating woman (negative result of baseline blood test)

6. Participation in another interventional study within 28 days before randomization or during this study

7. Person deprived of liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults,

8. Patient under the protection of justice, patient under guardianship or curatorship.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Rouen

Rouen, , France

Countries

France

References

Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

Reference Type: DERIVED

PMID: 36645250 (View on PubMed)

Palmier M, Bubenheim M, Chiche L, Chaufour X, Koskas F, Fadel E, Magnan PE, Ducasse E, Chakfe N, Steinmetz E, Dusseaux MM, Ricco JB, Plissonnier D. Protocol of supra-visceral aortic ischemic preconditioning for open surgical repair of thoracoabdominal aortic aneurysm : The EPICATA study (Evaluation of the Efficacy of Ischemic PreConditioning on morbidity and mortality in open ThoracoAbdominal Aortic surgery). BMC Surg. 2020 Aug 27;20(1):193. doi: 10.1186/s12893-020-00851-3.

Reference Type: DERIVED

PMID: 32854681 (View on PubMed)

Other Identifiers

2017/388/HP

Identifier Type: -

Identifier Source: org_study_id