The impact of REStrictive versUs Liberal Transfusion strategy on cardiac injury and death in patients undergoing surgery for Hip Fracture (RESULT-Hip)
Blood transfusion for recovery from hip surgery
Current interventions as of 03/07/2025: To answer the study question accurately we will need to recruit 842 patients, they will be split between the two arms of the study. This will allow us to detect a difference in the main outcome. This figure has been calculated using information from our previous pilot study and allows for some patients to drop out of the study. The whole project will take 69 months to complete. However, each patient is only actively involved for 120 days post-randomisation. _____ Previous interventions as of 17/11/2023: RESULT-Hip is a multicentre randomised trial of the effect of two blood transfusion strategies in patients with hip fractures on cardiac complications. One group of patients will have a restrictive transfusion strategy, which follows published guidelines, and the other a more liberal strategy. This is described more fully below. The study will take place in 30 UK hospitals that look after patients with hip fractures. When a patient is admitted to the hospital after breaking their hip, almost all go on to have surgery to treat this condition. They will be assessed by the clinical team or research team (where part of the clinical team) in the hospital to see if they meet the age inclusion criteria and do not have any exclusion criteria for the study. Those receiving palliative care (i.e. do not have surgery), who have life-threatening haemorrhage at the time of screening, pre-randomisation acute, or suspected acute, coronary syndrome, objection to receiving RBC transfusion or chronic transfusion-dependent anaemia, will be excluded. This can take place from the time the patient enters the hospital and up to and including 7 days post-surgery. If the patient meets the criteria they will be approached by a member of the clinical team or research team (where part of the clinical team) to discuss whether they are interested in taking part in the study. If they are, a member of the research team will take consent from the patien
Current participant inclusion criteria as of 17/11/2023: 1. Adults aged 60 years or over 2. Admission to acute unit for operative management of hip fracture For Randomisation: 3. Presence of anaemia (Haemoglobin equal to or less than 90 g/L) at any point between the date of admission to hospital up to and including seven days after surgery _____ Previous participant inclusion criteria: 1. Adults aged 60 years or over 2. Admission to hospital for operative management of hip fracture For Randomisation: 3. Presence of anaemia (Haemoglobin equal to or less than 90 g/L) at any point between the date of admission to hospital up to and including seven days after surgery
Current exclusion criteria as of 03/07/2025: 1. Objection to RBC transfusion 2. Unable to obtain consent (from patient or in accordance with appropriate mental capacity legislation for site) 3. Patients for non-operative management or not expected to survive 48 hours 4. Patients with a new or suspected acute coronary syndrome meeting 4th Universal Definition during current admission 5. Rapid or uncontrolled blood loss resulting in haemodynamic instability 6. Chronic anaemia requiring repeated transfusion (eg Myelodysplasia or bone marrow failure syndromes) _____ Previous participant exclusion criteria as of 17/11/2023: 1. Objection to RBC transfusion 2. Unable to obtain consent (from patient or in accordance with appropriate mental capacity legislation for site) 3. Patients for non-operative management or not expected to survive 48 hours 4. Patients with a new or suspected acute coronary syndrome meeting 4th Universal Definition during current admission 5. Rapid or uncontrolled blood loss resulting in haemodynamic instability 6. Transfusion dependent/chronic anaemias (eg Myelodysplasia or bone marrow failure syndromes) _____ Previous participant exclusion criteria: 1. Objection to RBC transfusion 2. Unable to obtain consent (from patient or in accordance with appropriate mental capacity legislation for site) 3. Patients for non-operative management or not expected to survive 48 hours 4. Patients with a new acute coronary syndrome meeting 4th Universal Definition during current admission 5. Rapid or uncontrolled blood loss resulting in haemodynamic instability