Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial.

BACKGROUND

During total aortic arch replacement surgery (TARS) for patients with acute type A aortic dissection, the organs in the lower body, such as the viscera and spinal cord, are at risk of ischemia even when antegrade cerebral perfusion (ACP) is performed. Combining ACP with retrograde inferior vena caval perfusion (RIVP) during TARS may improve outcomes by providing the lower body with oxygenated blood.

METHODS

This study is designed as a multicenter, computer-generated, randomized controlled, assessor-blind, parallel-group study with a superiority framework in patients scheduled for TARS. A total of 636 patients will be randomized on a 1:1 basis to a moderate hypothermia circulatory arrest (MHCA) group, which will receive selective ACP with moderate hypothermia during TARS; or to an RIVP group, which will receive the combination of RIVP and selective ACP under moderate hypothermia during TARS. The primary outcome will be a composite of early mortality and major complications, including paraplegia, postoperative renal failure, severe liver dysfunction, and gastrointestinal complications. All patients will be analyzed according to the intention-to-treat protocol.

DISCUSSION

This study aims to assess whether RIVP combined with ACP leads to superior outcomes than ACP alone for patients undergoing TARS under moderate hypothermia. This study seeks to provide high-quality evidence for RIVP to be used in patients with acute type A aortic dissection undergoing TARS.

TRIAL REGISTRATION

Clinicaltrials.gov, ID: NCT03607786 . Registered on 30 July 2018.