Evidence map›Paper›PMID 32444994›Full record

ArticleCardiovascular drugs and therapy2020

"BAX602" in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial.

Satsuki Fukushima, Koko Asakura, Toshimitsu Hamasaki, Kaori Onda, Takuya Watanabe, Akira Shiose, Minoru Ono, Norihide Fukushima, Haruko Yamamoto, Tomoyuki Fujita

Open access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Cardiovascular drugs and therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 91% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

10 authors at 4 institutions in 2 countries.

Satsuki FukushimaDepartment of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan. s.fukushima@ncvc.go.jp.ORCID 0000-0002-9481-8860
Koko AsakuraDepartment of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Toshimitsu HamasakiThe Biostatistics Center and Department of Biostatistics and Bioinformatics, George Washington University, Washington, DC, USA.
Kaori OndaDepartment of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Takuya WatanabeDepartment of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
Akira ShioseDepartment of Cardiovascular Surgery, Kyushu University Hospital, Fukuoka, Japan.
Minoru OnoDepartment of Cardiac Surgery, The University of Tokyo, Tokyo, Japan.
Norihide FukushimaDepartment of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
Haruko YamamotoDepartment of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.
Tomoyuki FujitaDepartment of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan.
National Cerebral and Cardiovascular Center · JPGeorge Washington University · USKyushu University Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure. METHODS AND

designThis investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2-12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5). ETHICS AND DISSEMINATION: The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals.

trial registrationThe trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020.

Indexed as

Heart-Assist DevicesRandomized Controlled Trials as TopicVentricular Function, LeftAdolescentAdultAerosolsAgedFemaleHeart DiseasesHeart FailureHumansJapanMaleMiddle AgedMulticenter Studies as TopicPolyethylene GlycolsAerosolsBAX602Polyethylene GlycolsAdhesion prevention deviceCardiac surgeryMulticenter randomized trialVentricular assist device

Identifiers

PMID32444994
PMCPMC7497303
OpenAlexW3026874027

What OpenQuestion holds

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Registered trials

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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.