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

Jing Lin, Zhaoxia Tan, Hao Yao, Xiaolin Hu, Dafa Zhang, Yuan Zhao, Jiyue Xiong, Bo Dou, Xueshuang Zhu, Zhong Wu, Yingqiang Guo, Deying Kang, Lei Du, Jing Lin, Zhaoxia Tan, Hao Yao, Xiaolin Hu, Dafa Zhang, Yuan Zhao, Jiyue Xiong, Bo Dou, Xueshuang Zhu, Zhong Wu, Yingqiang Guo, Deying Kang, Lei Du

Abstract

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.

Keywords: Antegrade cerebral perfusion; Cardiac arrest; Hypothermia; Retrograde inferior vena caval perfusion; Type A aortic dissection.

Conflict of interest statement

Ethics approval and consent to participate

The clinical trial is being conducted in line with the Declaration of Helsinki. The study protocol has been approved by the Biomedical Ethics Committee of West China Hospital (ref approval no. 201824). All patients must be informed about the trial and give written informed consent in order to be enrolled.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrollment, intervention, and assessment according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement. ACP selective antegrade cerebral perfusion, MHCA moderate hypothermic circulatory arrest, RIVP retrograde inferior vena caval perfusion, POD postoperative day, EUROSCOREII European System for Cardiac Operative Risk Evaluation II, CPB cardiopulmonary bypass, ICU intensive care unit
Fig. 2
Fig. 2
Flow chart of the clinical trial

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