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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.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods and Design<\/jats:title>\n<jats:p>This 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\u201312\u00a0weeks 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\u2009=\u2009no adhesion; 1\u2009=\u2009filmy and avascular adhesion; 2\u2009=\u2009dense\/vascular adhesion; 3\u2009=\u2009cohesive 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).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Ethics and Dissemination<\/jats:title>\n<jats:p>The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial Registration<\/jats:title>\n<jats:p>The trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020<jats:bold>.<\/jats:bold><\/jats:p>\n<\/jats:sec>","DOI":"10.1007\/s10557-020-06990-2","type":"journal-article","created":{"date-parts":[[2020,5,22]],"date-time":"2020-05-22T06:02:45Z","timestamp":1590127365000},"page":"651-657","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["\u201cBAX602\u201d in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial"],"prefix":"10.1007","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9481-8860","authenticated-orcid":false,"given":"Satsuki","family":"Fukushima","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koko","family":"Asakura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshimitsu","family":"Hamasaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaori","family":"Onda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takuya","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akira","family":"Shiose","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Minoru","family":"Ono","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norihide","family":"Fukushima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haruko","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomoyuki","family":"Fujita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,5,22]]},"reference":[{"key":"6990_CR1","doi-asserted-by":"publisher","first-page":"S23","DOI":"10.1016\/j.athoracsur.2009.05.056","volume":"88","author":"SM O'Brien","year":"2009","unstructured":"O'Brien SM, Shahian DM, Filardo G, et al. 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The funder has no role in the study design, data collection and analysis, interpretation of results, manuscript preparation, or decision to publish. The authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interests"}},{"value":"All procedures performed in studies involving human participants were in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards, and with the Japanese Pharmaceutical Affairs Act and related laws and regulations. The protocol was approved by the National Cerebral and Cardiovascular Center Institutional Review Board and will be approved by each institutional review board of all participating centers before patient enrollment begins. A clinical trial notification for an investigational device exemption was accepted by the Japanese regulatory agency before trial commencement. Written informed consent will be obtained from all patients when they are recruited. Personal information about potential and enrolled participants will remain confidential, and data will be de-identified using participant numbers.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval and Consent to Participate"}}]}}