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

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.

SUBMITTER: Lin J

PROVIDER: S-EPMC6480889 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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

Lin Jing J Tan Zhaoxia Z Yao Hao H Hu Xiaolin X Zhang Dafa D Zhao Yuan Y Xiong Jiyue J Dou Bo B Zhu Xueshuang X Wu Zhong Z Guo Yingqiang Y Kang Deying D Du Lei L

Trials 20190424 1

<h4>Background</h4>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.<h4>Methods</h4>This study is designed as a multicenter, computer-generated, ra ...[more]

PMID: 31014386

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Project description:ObjectivesAntegrade cerebral perfusion (ACP) under moderate hypothermic circulatory arrest is used during total aortic arch replacement surgery (TARS) in patients with acute type A aortic dissection, but it is associated with high mortality and morbidity. We hypothesized that combining ACP with retrograde inferior vena caval perfusion (RIVP) improves outcomes.MethodsThis pilot study was prospective, randomized, controlled and assessor-blinded. Patients scheduled for TARS were randomly treated with either ACP or RIVP + ACP. The primary outcome was a composite of mortality and major complications including paraplegia, postoperative renal failure, severe liver dysfunction, and gastrointestinal complications. Secondary outcomes included neurological complications, length of intubation and requirement of blood products.ResultsA total of 76 patients were recruited (n = 38 per group). Primary outcome occurred in 23 patients (61%) in the ACP group and 16 (42%) in the RIVP + ACP group (OR: 0.60, 95% CI: 0.21-1.62; p = 0.31). There was a lower incidence of transient neurological deficits in the RIVP + ACP group (26% vs. 58%, OR: 0.26; 95% CI: 0.10-0.67,p = 0.006;). The RIVP + ACP group underwent shorter intubation (25 vs 47 h, p = 0.022) and required fewer blood products (red cells, 3.8 units vs 6.5 units, p = 0.047; platelet: 2.0 units vs 2.0 units, p = 0.023) compared with the ACP group.ConclusionsRIVP + ACP may be associated with lower incidence of transient neurological deficits, shorter intubation and less blood transfusion requirement than ACP alone during TARS. Multi-center, randomized trials with larger samples are required to determine whether RIVP + ACP is associated with lower rates of mortality and major complications.Trial registrationPilot study of a RCT registered in clinicaltrials.gov (NCT03607786), Registered 30 July, 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03607786 .

Project description:BackgroundStanford type A aortic dissection (TAAD) has a sudden onset and high mortality, and emergency total aortic arch replacement (TAAR) is the main treatment option for TAAD. The mortality rate of patients with postoperative acute kidney injury (AKI) combined with continuous renal replacement therapy (CRRT) is remarkable higher than that of patients without AKI. However, incidence of AKI and risk factors for CRRT following TAAR isn't entirely understood.MethodsFrom October 2018 to March 2021, all patients with Stanford type A dissection who underwent total arch replacement surgery under MHCA were enrolled. According to whether CRRT treatment was performed, participants were divided into a CRRT group (n=49) and control group (n=72). Both groups incorporated the brain protection strategy of moderate hypothermia, and the left common carotid artery and the innominate artery were perfused anteriorly. Relevant medical data was collected.ResultsAge, gender, and a history of smoking and drinking were not significantly different between the 2 groups (P>0.1). There were statistical differences between the 2 groups in aortic sinus diameter and Bentall procedure (P≤0.05). Univariate analysis revealed that fresh frozen plasma was a protective factor (P<0.05) and the intraoperative transfusion volume of red blood cells, platelets, fresh frozen plasma, autologous blood used for intraoperative bleeding, aortic sinus diameter, and Bentall procedure were risk factors (P<0.1). Multivariate analysis showed that the Bentall procedure and intraoperative bleeding were risk factors for CRRT (P<0.05), and the aortic sinus diameter and intraoperative transfusion score were also risk factors for CRRT (P<0.05). Receiver operating characteristic (ROC) analysis demonstrated that the model of aortic sinus diameter and intraoperative transfusion score had more significantly different discriminatory powers.ConclusionsThe Bentall procedure, intraoperative bleeding, aortic sinus diameter, and intraoperative transfusion score were risk factors for postoperative CRRT. The model of aortic sinus diameter and intraoperative transfusion score had more significantly different discriminatory powers.

Dataset Information

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

Publications

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

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