NCT03718312: EPICATA

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

Completed NA Last updated 18 September 2023

What this trial tests

NA trial testing clamping with pre-conditioning (PCl) in Aortic Aneurysm in 65 participants. Completed in 29 July 2023.

Timeline

29 July 2019

Primary endpoint
11 July 2023

29 July 2023

Quick facts

Lead sponsor	University Hospital, Rouen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	65
Start date	29 July 2019
Primary completion	11 July 2023
Estimated completion	29 July 2023
Sites	1 location across France

Drugs / interventions tested

• clamping with pre-conditioning (PCl)

Conditions studied

• Aortic Aneurysm — all drugs for Aortic Aneurysm →
• Surgery — all drugs for Surgery →

Sponsor

University Hospital, Rouen

Who can join

Adults 18 to 85, any sex, with Aortic Aneurysm or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Palmier M, Bubenheim M, Chiche L, Chaufour X, et al · · 2020 · cited 2× · PMID 32854681 · DOI 10.1186/s12893-020-00851-3