title: A multi-centre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and healthcare resource use following cardiac surgery: study protocol.
abstract: Thresholds for red blood cell transfusion following cardiac surgery vary by hospital and surgeon. The TITRe2 multi-centre randomised controlled trial aims to randomise 2000 patients from 17 United Kingdom centres, and tests the hypothesis that a restrictive transfusion threshold will reduce postoperative morbidity and health service costs compared to a liberal threshold. Patients consent to take part in the study pre-operatively but are only randomised if their haemoglobin falls below 9 g/dL during their post-operative hospital stay. The primary outcome is a binary composite outcome of any serious infectious or ischaemic event in the first three months after randomisation. Many challenges have been encountered in the set-up and running of the study.
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, UK.
authors.forename: Rachel C M
authors.initials: RC
authors.lastname: Brierley
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, UK.
authors.forename: Katie
authors.initials: K
authors.lastname: Pike
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, UK.
authors.forename: Alice
authors.initials: A
authors.lastname: Miles
authors.affiliation: Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Old Road, Headington, Oxford OX3 7LF, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Wordsworth
authors.affiliation: Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Old Road, Headington, Oxford OX3 7LF, UK.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Stokes
authors.affiliation: Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2 8HW, UK.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Mumford
authors.affiliation: Directorate of Specialised Services, Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8HW, UK.
authors.forename: Alan
authors.initials: A
authors.lastname: Cohen
authors.affiliation: Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2 8HW, UK.
authors.forename: Gianni D
authors.initials: GD
authors.lastname: Angelini
authors.affiliation: Department of Cardiovascular Sciences, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester LE3 9QP, UK.
authors.forename: Gavin J
authors.initials: GJ
authors.lastname: Murphy
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, UK.
authors.forename: Chris A
authors.initials: CA
authors.lastname: Rogers
authors.affiliation: Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, UK. Electronic address: Barney.Reeves@bristol.ac.uk.
authors.forename: Barnaby C
authors.initials: BC
authors.lastname: Reeves
mesh_terms: D001803:Blood Transfusion; D006348:Cardiac Surgical Procedures; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000097:blood / Q000401:mortality / Q000628:therapy; D012189:Retrospective Studies; D013997:Time Factors; D006113:United Kingdom
chemical_list: D006454:Hemoglobins
keywords: Cardiac surgery; Protocol; Red cell; Restrictive; Transfusion