{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T20:38:01Z","timestamp":1793738281897,"version":"4.6.1"},"reference-count":17,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2023,12,28]],"date-time":"2023-12-28T00:00:00Z","timestamp":1703721600000},"content-version":"unspecified","delay-in-days":27,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"XVIVO Perfusion AB, M\u00e4ssans gata 10","award":["41251"],"award-info":[{"award-number":["41251"]}],"id":[{"id":"https:\/\/ror.org\/03z5ydt44","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,12,11]]},"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Ischaemic cold static storage (ICSS) is the gold standard in donor heart preservation. This ischaemic time frame renders a time constraint and risk for primary graft dysfunction. Cold oxygenated heart perfusion, known as non-ischaemic heart preservation (NIHP), theoretically limits the ischaemic time, while holding on to the known advantage of hypothermia and cardioplegia, a low metabolic rate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The NIHP 2019 study is an international, randomised, controlled, open, multicentre clinical trial in 15 heart transplantation centres in 8 European countries and includes 202 patients undergoing heart transplantation, allocated 1:1 to NIHP or ICSS. Enrolment is estimated to be 30 months after study initiation. The patients are followed for 12 months after transplantation.<\/jats:p>\n                    <jats:p>The primary objective is to evaluate the effect of NIHP on survival, allograft function and rejection episodes within the first 30 days after transplantation. The secondary objectives are to compare treatment groups with respect to survival, allograft function, cardiac biomarkers, rejection episodes, allograft vasculopathy, adverse events and adverse device effects within 12 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This protocol was approved by the Ethics Committee (EC) for Research UZ\/KU Leuven, Belgium, the coordinating EC in Germany (Bei Der LMU M\u00fcnchen), the coordinating EC in the UK (West Midlands\u2014South Birmingham Research), the EC of Hospital Puerta de Hierro, Madrid, Spain, the EC of G\u00f6teborg, Sweden, the coordinating EC in France, the EC of Padova, Italy and the EC of the University of Vienna, Austria. This study will be conducted in accordance with current local regulations and international applicable regulatory requirements according to the principles of the Declaration of Helsinki and ISO14155:2020. Main primary and secondary outcomes will be published on modified intention-to-treat population and per-protocol population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03991923\">NCT03991923<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-073729","type":"journal-article","created":{"date-parts":[[2023,12,28]],"date-time":"2023-12-28T12:15:49Z","timestamp":1703765749000},"page":"e073729","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":21,"title":["Non-ischaemic preservation of the donor heart in heart transplantation: protocol design and rationale for a randomised, controlled, multicentre clinical trial across eight European countries"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct03991923","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03150147","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1925-9269","authenticated-orcid":false,"given":"Janne","family":"Brouckaert","sequence":"first","affiliation":[{"name":"Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00f6ran","family":"Dellgren","sequence":"additional","affiliation":[{"name":"Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Wallinder","sequence":"additional","affiliation":[{"name":"XVIVO Perfusion AB, Gothenburg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filip","family":"Rega","sequence":"additional","affiliation":[{"name":"Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,12,28]]},"reference":[{"key":"2025101815031314000_13.12.e073729.1","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1016\/j.healun.2017.07.016","article-title":"The registry of the International society for heart and lung transplantation: thirty-fourth adult heart transplantation report; 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