Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study

Khadra Galaal, Alberto Lopes, Colin Pritchard, Andy Barton, Jennifer Wingham, Elsa Marques, John Faulds, Joanne Palmer, Patricia Vickery, Catherine Ralph, Nicole Ferreira, Paul Ewings

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Abstract

Introduction: Ovarian cancer is the leading cause of death from gynaecological cancer, with more than 7000 new cases registered in the UK in 2014. In patients
suitable for surgery, the National Institute of Health and Care Excellence guidance for treatment recommends surgical resection of all macroscopic tumour, followed by chemotherapy. The surgical procedure can be extensive
and associated with substantial blood loss which is conventionally replaced with a donor blood transfusion. While often necessary and lifesaving, the use of donor blood is associated with increased risks of complications and adverse surgical outcomes. Intraoperative cell salvage (ICS) is a blood conservation strategy in which red cells collected from blood lost during surgery are returned to the patient thus minimising the use of donor blood. This is the protocol for a feasibility randomised controlled trial with an embedded qualitative study and feasibility economic evaluation. If feasible, a later definitive trial will test the
effectiveness and cost-effectiveness of ICS reinfusion versus donor blood transfusion in ovarian cancer surgery.

Methods and analysis: Sixty adult women scheduled for primary or interval ovarian cancer surgery at participating UK National Health Service Trusts will be recruited and individually randomised in a 1:1 ratio to receive ICS reinfusion or donor blood (as required) during surgery. Participants will be followed up by telephone at 30 days postoperatively for adverse events monitoring and by
postal questionnaire at 6weeks and 3monthly thereafter, to capture quality of life and resource use data. Qualitative interviews will capture participants’ and clinicians’ experiences of the study.

Ethics and dissemination: This study has been granted ethical approval by the South West–Exeter Research Ethics Committee (ref: 16/SW/0256). Results will be disseminated via peer-reviewed publications and will inform the design
of a larger trial.

Trial registration number: ISRCTN19517317.
Original languageEnglish
Article numbere024108
Number of pages9
JournalBMJ Open
Volume8
Early online date1 Nov 2018
DOIs
Publication statusPublished - Nov 2018

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Galaal, K., Lopes, A., Pritchard, C., Barton, A., Wingham, J., Marques, E., Faulds, J., Palmer, J., Vickery, P., Ralph, C., Ferreira, N., & Ewings, P. (2018). Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study. BMJ Open, 8, [e024108]. https://doi.org/10.1136/bmjopen-2018-024108