Trial Status - In Set-Up
A multi-centre feasibility study for a randomised controlled trial of intra operative cell salvage versus standard care in patients undergoing surgery for a fractured hip
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 elses 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.
In this application, before a large study, we propose a preliminary study to evaluate:
• The willingness of doctors specialising in hip fracture surgery to enrol patients,
• Patients and next of kin/ carers acceptance of the proposed study,
• Whether sufficient blood is lost, and can be processed, in order to make cell salvage viable, in patients undergoing hip fracture surgery.
If this study shows it to be possible, we will apply separately for funding for a large definitive study. 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.
Only an adequately powered full randomised controlled trial (RCT) will tell us whether cell salvage is clinically and cost effective. In this application, before a full RCT, we propose a feasibility trial to evaluate: Clinician willingness to randomise patient, Patients acceptance of a RCT, whether sufficient blood is lost, and can be processed, in order to make cell salvage viable, in patients undergoing hip fracture surgery.
We will conduct a multicentre feasibility RCT comparing cell salvage and autotransfusion with standard care, within an existing multicentre cohort (WHITE) we have developed. Patients over 60 years of age who sustain a hip fracture and are treated operatively, will be randomised to receive cell salvage and autotransfusion or standard care.