Evidence map›Paper›PMID 33228727›Full record

Trial reportTrials2020

Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial.

Jing Yang, Dong Ji, Yue-Qian Zhu, Yun Ren, Xun Zhang, Hong-Yu Dai, Xu Sun, Yi Zhou, Zhi-Yuan Chen, Qing-Guo Li and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04007484 (The Effects of Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact, top 75% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04007484 naunknown statusnot on this map

The Effects of Hemoperfusion in Acute Type A Aortic Dissection Patients Undergoing Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest: A Randomized, Controlled, Double-blinded Trial

TypeinterventionalSponsorThe Second Hospital of Nanjing Medical UniversityRan2019 to 2020Enrolled88ConditionsAcute Type A Aortic Dissection With Arch Involvement, Cardiopulmonary Bypass, Deep Hypothermic Circulatory ArrestArmsHemoperfusion
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Jing YangCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Dong JiCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Yue-Qian ZhuCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Yun RenCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Xun ZhangCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Hong-Yu DaiCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Xu SunCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Yi ZhouCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Zhi-Yuan ChenCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China.
Qing-Guo LiCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China. liqg@njmu.edu.cn.
Hao YaoCardiovascular Center, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu Province, China. yaohao@njmu.edu.cn.ORCID http://orcid.org/0000-0002-5246-5550
Second Affiliated Hospital of Nanjing Medical University · CN

Funding

National Natural Science Foundation of China 81670421Postgraduate Research & Practice Innovation Program of Jiangsu Province SJCX190426
6 · The paper itself

Abstract

backgroundCardiopulmonary bypass (CPB) is an important cause of significant systemic inflammatory response syndrome (SIRS) in the surgical treatment of acute type A aortic dissection (ATAAD). In patients with arch vessel involvement, extensive surgical repairs often necessitate prolonged use of CPB and results in extensive inflammatory responses. Cytokines and chemokines released during CPB contribute to the progression of SIRS, increase perioperative complications, and negatively impact surgical outcomes. A cytokine adsorber (HA380) is expected to reduce the level of cytokines during CPB, which may decrease both intraoperative and postoperative inflammation. The purpose of this study is to investigate if HA380 is able to reduce the levels of inflammatory cytokines and decrease perioperative complications in ATAAD patients undergoing CPB and deep hypothermic circulatory arrest (DHCA).

methodsThis study is a single-center, randomized, controlled, double-blind clinical trial. The study aims to recruit 88 patients with ATAAD and aortic arch involvement who will undergo CPB and DHCA to repair the dissected aorta. Patients will be randomized equally into the CPB/DHCA only group (control group) and the CPB/DHCA + HA380 hemoperfusion group (intervention group), with 44 patients each. Patients in the control group will undergo CPB and DHCA only, while patients in the intervention group will undergo continuous hemoperfusion with HA380, in addition to CPB and DHCA. The primary outcome is a composite of major perioperative complications. The secondary outcomes include related inflammatory markers, coagulation parameters, and minor perioperative complications. To comprehensively evaluate the effect of hemoperfusion on the perioperative outcomes, we will also determine if there are differences in perioperative all-cause mortality, length of ICU stay, and total hospitalization costs. DISCUSSION: In the current trial, hemoperfusion will be applied in patients undergoing CPB and DHCA for repair of the aorta involving the aortic arch. This trial aims to test the safety and efficacy of our hemoperfusion device (HA380) in such settings. Upon completion of the trial, we will determine if HA380 is effective in reducing perioperative proinflammatory cytokine levels. Further, we will also verify if reduction in the proinflammatory cytokine levels, if present, translates to improvement in patient outcomes.

trial registrationClinicalTrials.gov NCT04007484 . Registered on 1 July 2019 (retrospectively registered).

Indexed as

Aortic DissectionHemoperfusionAorta, ThoracicCardiopulmonary BypassCirculatory Arrest, Deep Hypothermia InducedHumansTreatment OutcomeAcute type A aortic dissectionCardiopulmonary bypassCoagulation indicatorsDeep hypothermic circulatory arrestHA380Inflammatory factors

Identifiers

PMID33228727
PMCPMC7684885
OpenAlexW3107173713

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.