The impact of REStrictive versUs LIberaL Transfusion strategy on cardiac injury and death in patients undergoing surgery for Hip Fracture (RESULT-Hip)
Hip fracture is the most common serious injury in older people. More than 95% go on to have surgery. This surgery is often high-risk as patients with hip fracture may already be frail and have other health problems including heart disease and anaemia. Patients may be in hospital for a long time and need rehabilitation. Up to 35% of surviving patients do not return to their original place of residence and have a high rate of increased dependency.
Research suggests that 30-40% of these patients have a blood transfusion around the time of operation, but doctors are uncertain about what level of anaemia (a low blood count) transfusions should be given. Many current guidelines recommend transfusion at a lower level but there is research which suggests this level is too low particularly if the patient has a history of heart disease. In these patients, transfusion at a higher level may be better to prevent complications.
In this study people 60 years or older with hip fracture that become anaemic will be randomly assigned to be transfused at one of two different blood count levels. Either a lower blood count level in line with current guidelines or a higher blood count level, for the duration of their hospital stay or 30 days whichever is soonest. Participants will have their blood count checked before and after any blood transfusions and will have additional blood tests and ECG to check their heart.
At 30 days we will measure how often post-operative heart attacks and other complications occur’ how long patients stay in hospital and mortality rate. At 30 and 120 days we will measure quality of life and use of health services.
The study results will help doctors looking after people with hip fracture decide when is the best time to give blood transfusions .
Chief Investigator: Professor Michael Gillies, Consultant in Anaesthesia, Critical Care and Pain Medicine
Number and location of participating sites (by region/ country): 30 UK sites
EudraCT number: N/A
ISRCTN number: 28818784
Funder: National Institute for Health Research Health Technology Assessment
Start and End date
Of grant award: 01 August 2021 - 31 July 2025
Of recruitment: 10th June 2022
Current Status: In set up
Trial Website: The RESULT-HIP Study
UK GDPR Privacy Statement: As part of Patient Information Sheet
Co-sponsor Representative: The University of Edinburgh and NHS Lothian http://accord.scot/
Chief Investigator: Professor Michael Gillies, Consultant in Anaesthesia, Critical Care and Pain Medicine, Dept of Anaesthesia, Critical Care and Pain Medicine
The Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA Michael.Gillies@ed.ac.uk
Gayle Beveridge, Edinburgh Clinical Trials Unit, USHER Institute, NINE Edinburgh BioQuarter, 9 Little France Road, Edinburgh , EH16 4UX Gayle.Beveridge@ed.ac.uk
ECTU involvement: Trial management / Statistics / Health Economics / Data management /Database management/ Randomisation service