Dataset Information

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:BACKGROUND:Pulmonary emboli (PE) can have potentially fatal consequences. Inferior vena caval filters (VCFs) are metal alloy devices that mechanically trap fragmented thromboemboli from the deep leg veins en route to the pulmonary circulation. Filters are designed to be introduced (and in the case of retrievable filters, removed) percutaneously. Although their deployment seems of theoretical benefit, their clinical efficacy and adverse event profile is unclear.This is an update of a Cochrane review first published in 2007. OBJECTIVES:To examine evidence for the effectiveness of VCFs in preventing pulmonary embolism (PE). Secondary outcomes were mortality, distal (to filter) thrombosis, and filter-related complications. SEARCH STRATEGY:The Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched October 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2009, Issue 4 for randomised or controlled clinical trials of VCFs for the prevention of PE. The authors contacted filter manufacturers for information. SELECTION CRITERIA:Controlled clinical trials (CCTs) and randomised controlled trials (RCTs) that examined the efficacy of filters in preventing PE. DATA COLLECTION AND ANALYSIS:Two authors independently extracted information. MAIN RESULTS:Two studies were included involving a total of 529 people. One open quasi-randomised trial of 129 participants with traumatic hip fractures showed a reduction in PE but not mortality over a 34 day period in the filter group. The PREPIC (Prévention du Risque d'Embolie Pulmonaire par Interruption Cave) trial, was an open RCT of 400 participants with documented proximal deep vein thrombosis (DVT) or PE who received concurrent anticoagulation. Permanent VCFs prevented PE at eight years. No reduction in mortality was seen, but this reflected an older study population; the majority of deaths were due to cancer or cardiovascular causes. There was an increased incidence of (DVT) in the filter group. Adverse events were not reported. AUTHORS' CONCLUSIONS:No recommendations can be drawn from the two studies. One study showed a reduction in PE rates but not mortality, but was subject to significant biases. The PREPIC study lacked statistical power to detect a reduction in PE over shorter and more clinically significant time periods. However, the trial demonstrated that permanent VCFs were associated with an increased risk of long term lower limb DVT.There is a paucity of VCFs outcome evidence when used within currently approved indications and a lack of trials on retrievable filters. Further trials are needed to assess vena caval filter safety and effectiveness.

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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