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

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 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 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.

Cell salvage for postpartum haemorrhage during vaginal delivery: a case series.

BACKGROUND: The safety and effectiveness of cell salvage for vaginal delivery is unknown. This case series aimed to assess the utility and adverse events related to the use of cell salvage for maternal haemorrhage during vaginal delivery. MATERIALS AND METHODS: A cohort study design was chosen, focused on postpartum haemorrhages that occurred after vaginal delivery for which cell salvage equipment was requested to be set up in the labour and delivery room outside of a sterile operating room environment. Variables recorded included duration of stay in hospital, occurrence of wound infections, sepsis, thromboembolic events, and amniotic fluid embolism. RESULTS: Of 28 cases of postpartum haemorrhage during vaginal deliveries involving the setup or use of cell salvage equipment, ten were associated with successful re-infusion of salvaged shed blood. These ten cases were compared to the 18 cases in which cell salvage equipment was set up, but insufficient shed blood was salvaged for re-infusion. There were no instances of postpartum sepsis, wound infection, or thromboembolism associated with the use of cell salvage for vaginal delivery. Although one case of suspected amniotic fluid embolism occurred, severe symptoms began prior to the infusion of salvaged blood. DISCUSSION: Infusion of salvaged shed blood collected from a vaginal delivery field is feasible. The outcomes of these cases do not exclude an unacceptably high risk of infection or embolic events. Trials evaluating the safety and effectiveness associated with the use of cell salvage in vaginal deliveries are justified.

A randomised controlled trial investigating the effects of dopexamine on gastrointestinal function and organ dysfunction in the critically ill.

OBJECTIVE: To determine whether an infusion of dopexamine for up to 7 days has an effect on gastrointestinal (GIT) absorption and permeability, renal function or organ dysfunction in the critically ill. DESIGN AND SETTING: Prospective, randomised controlled clinical trial in two general adult intensive care units. PATIENTS: 102 critically ill adult patients predicted to require organ support for at least 4 days. INTERVENTIONS: After resuscitation patients were randomly assigned to receive an infusion of up to 2 mcg/kg/min [corrected] per minute of dopexamine or control. MEASUREMENTS AND RESULTS: GIT absorption and permeability were measured using the ratio of absorbed rhamnose to 3- O-methyl- D-glucose and the ratio of lactulose to rhamnose on days 1, 4 and 7. Creatinine clearance was measured concurrently. Daily Sequential Organ Failure Assessment scores were calculated. Fifty-two patients received dopexamine. No significant difference between the two groups emerged on any of the measured parameters during the study period. CONCLUSIONS: No benefit was seen from a prolonged infusion of dopexamine in this group of critically ill patients in terms of GIT absorption and permeability, creatinine clearance or organ dysfunction.