Trial Status: Closed to recruitment, in follow up
A multi centre randomised controlled trial comparing intra operative cell salvage with standard care in the treatment of hip fractures
Dedicated Trial Website
For more information on this trial, please visit the dedicated trial website by following the link below!
We want to improve the treatment of older adults with broken hips. The broken bone and the subsequent surgery mean patients inevitably lose considerable amounts of blood (about a pint on average), which can worsen their health and recovery. Blood transfusions can cause allergic reactions and increase the chance of patients developing an infection, risks that frailer patients can ill afford. We will test the benefit of collecting patients' own blood lost during surgery and transfusing it back to them - a method called cell salvage. This method is well known and used widely for other operations in the NHS, but until now has not been used for patients with a broken hip.
Every year 65,000 people in England, Wales and Northern Ireland break their hip and undergo surgery. This is a devastating injury for these typically elderly, frail and anaemic patients. As a result of the break and the surgery, 30% of patients require a transfusion of someone else's donated blood. This can lead to complications, increase the risk of infections (e.g. pneumonia or a wound infection) and increases the length of the hospital stay. Cell salvage recovers blood lost during surgery and transfuses it back to the patient. It is safe and effective at reducing the need for blood transfusions in other surgery, but has never been tested in patients with a broken hip. Only a large study comparing outcomes for patients where cell salvage was or was not used will tell us whether cell salvage helps patients having surgery for broken hips, and so whether it should be part of normal NHS practice.
The primary outcome for this trial will be health-related quality-of-life, measured using the EuroQol 5 dimensions score, at 4 months post-surgery. Secondary outcomes will include health-related quality-of-life at 12 months, complications, postoperative delirium, residential status, mobility, allogenic blood use, mortality and resource use.
Patients and members of the public have been involved in the design of the study and applying for funding. We will continue to involve these patients and members of the public in the day-to-day management and publicising the results of the study.
The trial will be embedded within the World Hip Trauma Evaluation (WHITE) Cohort.
Our aim is to determine the clinical and cost effectiveness of intraoperative cell salvage, compared to standard care, in improving health related quality-of-life in patients undergoing hip fracture surgery.For an adequate power of this study, we would need to recruit 1128 participants. Patients enrolled in the feasibility stage of this study will be included in the sample size of the full study.