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

IntroductionOvarian 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 analysisSixty 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 6 weeks and 3 monthly thereafter, to capture quality of life and resource use data. Qualitative interviews will capture participants’ and clinicians’ experiences of the study.Ethics and disseminationThis 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 numberISRCTN19517317.

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Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO)

PLoS Medicine ◽

10.1371/journal.pmed.1002471 ◽

2017 ◽

Vol 14 (12) ◽

pp. e1002471 ◽

Cited By ~ 22

Author(s):

Khalid S. Khan ◽

Philip A. S. Moore ◽

Matthew J. Wilson ◽

Richard Hooper ◽

Shubha Allard ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Blood Transfusion ◽

Cesarean Section ◽

Controlled Trial ◽

Cell Salvage ◽

Donor Blood ◽

Randomised Controlled

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Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-022352 ◽

2019 ◽

Vol 9 (2) ◽

pp. e022352 ◽

Cited By ~ 4

Author(s):

Carol McLoughlin ◽

Tracy E Roberts ◽

Louise J Jackson ◽

Philip Moore ◽

Matthew Wilson ◽

...

Keyword(s):

Cost Effectiveness ◽

Caesarean Section ◽

Blood Transfusion ◽

Controlled Trial ◽

Mean Difference ◽

Cell Salvage ◽

Donor Blood ◽

Intention To Treat ◽

The Mean ◽

Randomised Controlled

ObjectivesTo evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care.DesignModel-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section.Setting26 obstetric units in the UK.Participants3028 women at risk of haemorrhage recruited between June 2013 and April 2016.InterventionsCell salvage (intervention) versus routine care without salvage (control).Primary outcome measuresCost-effectiveness based on incremental cost per donor blood transfusion avoided.ResultsIn the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses.ConclusionsThe results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies.Trial registration numberISRCTN66118656.

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