Trial of Intra-Operative Cell Salvage Versus Transfusion in Ovarian Cancer (TIC TOC): A Randomised Controlled Feasibility Study

Abstract

Objectives: To evaluate the acceptability and feasibility of intraoperative cell salvage (ICS) in women with ovarian cancer. Design: Prospective multicentre randomised controlled feasibility trial. Setting: Four U.K. cancer centres Participants: Women with CT scan evidence supported FIGO stage III/IV ovarian cancer, Intervention group received ICS and control group received blood transfusion. Outcome measures: The acceptability and feasibility of ICS in women with ovarian cancer having cytoreductive surgery. Rates of recruitment for a larger trial and the likely completeness of resource use and outcome data. Blinding of allocation for participants and outcome assessors. Results: Between February 2017 and February 2018, 167 women were screened, and 57 women were enrolled. The mean age was 65 years for the ICS and 63 for the control group. The mean (SD) blood loss in the ICS group was 1022 ml (SD 929ml) and 924ml (SD 646ml) in the control group. 16 (62%) of the participants in the ICS arm received ICS reinfusion and 11 (42%) received donor blood, four intra-operatively three post-operatively and four intra- and post-operatively. In the donor blood group, 14 (48%) of the participants received donor blood, one had ICS and the remaining 14 had no transfusion. Follow-up data were available for 91% of participants (24 ICS, 28 donor) at 30 days post-operatively and for 75% of participants (22 ICS, 21 donor) at six weeks post-operatively. There was no difference in postoperative complications rate between the two groups. A total of six died during the course of the trial follow up. Conclusions: Our study shows that women with ovarian cancer are open to having ICS as an alternative to blood transfusion. ICS might work as an adjuvant or alternative to donor blood. Barriers to a definitive trial include staff and ICS machinery availability in theatre. An appropriately powered randomised controlled trial is now required to address these barriers and investigate the oncological impact of intraoperative cell salvage in women with ovarian cancer. Trial Registration: Trial registration: ISRCTN19517317 Funding: NIHR (RfPB) Programme PB-PG-1014-35005. Declaration of Interest: None to declare. Ethical Approval: We obtained ethics approval for the trial from the Southwest–Exeter Research Ethics Committee (ref: 16/SW/0256).