Extrait

Background and study aims Donated blood is a precious resource. Having blood available is essential for major procedures including joint replacement, cardiac surgery, organ transplantation, cancer care and the management of major trauma. When there is no blood available, this reduces the ability of the NHS to deliver high quality health care wherever it is needed, and all at the same time. There may be postponements or cancellation of operations if blood is required elsewhere. Intraoperative cell salvage (IOCS) collects the patient’s own blood lost during an operation, cleans it and returns it to their circulation. It reduces the amount of donor blood given in certain operations. Its use in Caesarean section (CS) has not yet been adequately examined. The National Institute of Clinical Excellence (NICE) recommends IOCS for massive blood loss in an emergency, but has called for evidence from clinical trials to support its routine use. This study will assess if IOCS during Caesarean section reduces the need to give a donor blood transfusion. Who can participate? Around 3050 women at risk of bleeding will be studied. As many women as possible booked at around 17 large obstetric units will be given information about the study, prior to birth. Those who deliver by Caesarean section and are eligible for the study will be asked if they would like to participate. What does the study involve? Half of the participants will be randomly allocated to IOCS during surgery, and half will receive usual care with donor blood transfusion if necessary. The necessity for transfusion will be recorded for each group. Other maternal health and cost outcomes will be collected. Participation in the study will be from the time of admission to hospital to the time of discharge. There will be no additional tests required but participants will be asked to complete a short questionnaire prior to discharge. The research team is hand-picked from regional centres across England, Scotland and Wales and includes national experts in obstetrics, anaesthesia, cell salvage, health technology assessment and health economics. What are the possible benefits and risks of participating? The benefits are uncertain (hence the need for the trial). There is a possibility that IOCS may reduce the need for donor blood transfusion, and the risks associated with this. Blood given during Caesarean section is from blood donations. All blood used in the UK is thoroughly screened for infections and is completely safe, as long as you are given the correct blood group. Very rarely, mistakes are made and the wrong blood group is given or the recipient has a reaction to the blood. IOCS may, by improving iron levels, allow women to leave hospital sooner and reduce the chance of side effects. There are two concerns about using the cell saver machine during Caesarean sections. Neither concern is related to the health of your baby. Historically, the cell saver was not used in Caesarean sections because it was thought that it might increase the chance of a woman developing a serious condition called 'Amniotic Fluid Embolism'. This is where some of the fluid surrounding the baby in the womb enters the mother's blood stream with serious consequences. More recent work shows that it is highly unlikely that IOCS could cause this condition, but we can never be 100% certain. The second concern is of Rhesus disease in any future babies. This can happen when a woman with the blood type known as 'rhesus-negative' (Rh-) has a baby with the blood type rhesus-positive (Rh+). If the mother's blood comes into contact with the baby's blood, the mother's immune system then produces antibodies that are capable of attacking her baby's blood cells and these antibodies are activated in all future pregnancies when the baby is Rh+. It is possible that the mother's blood can come into contact with the baby's blood during a normal delivery but it is also possible during the IOCS procedure. The exposure to baby's blood is measured using a test called the Kleihauer test. All rhesus-negative women who have a Caesarean section have an injection soon after delivery to prevent these antibodies developing; this is called an anti-D antibody injection. So, participation in the trial or having IOCS will not be any different from standard practice in preventing Rhesus disease. Where is the study run from? At least 17 large UK obstetric units in collaboration with the UKCRN registered Pragmatic Clinical Trials Unit (PCTU) at Bart's and the London School of Medicine. When is study starting and how long is it expected to run for? The study will start recruiting in June 2013 and will be completed in April 2016 Who is funding the study? National Institute of Health Research, Health Technology Assessment Programme (NIHR HTA). Who is the main contact? Professor Khalid Khan [email protected]

Critère d'inclusion

• Haemorrhage / Caesarean Section (CS)

Liens

• isrctn
• ictrp