The Trial of Intraoperative Cell Salvage Versus Transfusion in Ovarian Cancer (TIC TOC): Results of a Randomized Controlled Feasibility Study

<b>Objectives:</b> To evaluate the acceptability and feasibility of intraoperative cell salvage (ICS) in women with ovarian cancer. A prospective multicenter randomized controlled feasibility trial. <b>Setting:</b> Four U.K. cancer centers. Women FIGO stage III/IV ovarian cancer supported by CT scan evidence. We randomized women to receive ICS or donor blood (as required) during surgery for ovarian cancer. 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; and blinding of allocation for participants and outcome assessors. A total of 57 women were included; the rate of recruitment was 1.4 cases per month, which closely aligns with the target, and 66% of the eligible patients were recruited. Overall, 91% of women completed the 30-day follow-up, and 75% completed the six-week follow-up. Mean (SD) blood loss in the ICS group was 1022 mL (SD 929 mL) and 924 mL (SD 646 mL) in the control group. A total of 16 (62%) of the participants undergoing surgery in the ICS arm received ICS reinfusion. Of the ten participants in the intervention group who did not receive ICS, six participants lost a significant volume of blood requiring transfusion. In the donor blood group, 14 of the 29 participants received donor blood. In the ICS group, 20/24 (83%) of participants, and 23/24 (96%) of research nurses did not know their group allocation. In the control group, 24/28 (86%) and 25/29 (86%) of participants and research nurses did not know the group allocation. Our study provides clinical evidence of the feasibility and acceptability of using ICS in ovarian cancer surgery and provides useful insights into the use of ICS within clinical trials. Women are open to having ICS as an alternative to blood transfusion. An appropriately powered randomized controlled trial is now required.