Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial.

"availability of data and materials not applicable. declarations ethics approval and consent to participate the trial received research ethics approval from south central - berkshire b research ethics committee (iras ref: 234266"

"Declarations Ethics approval and consent to participateThe trial received research ethics approval from South Central – Berkshire B Research Ethics Committee (IRAS ref: 234266, REC ref: 8/SC/0472) and Medicines and Healthcare products Regulatory Agency (EUDRACT ref: 2018-000169-35) in September 2018. Patients provided written informed consent for use of their data. Consent for publicationNot applicable. Competing interestsThe authors declare that they have no competing interests. Competing interests The authors declare that they have no competing interests."

"Funding The ProMPT-2 trial (Project ref: 15/180/55) was funded by the Efficacy and Mechanism Evaluation (EME) Programme, an Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership. This trial was designed and delivered in collaboration with the Bristol Trials Centre, a UKCRC registered clinical trials unit, in receipt of NIHR Clinical Trials Unit (CTU) support funding until August 2023. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care. Funding agencies were not involved in the writing of the statistical analysis plan."

"Trial registration ISRCTN ISRCTN15255199. Registered on 26 March 2019."