Blood transfusion for recovery from hip surgery Surgery
Conditions
Interventions
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 dete
Sponsors
University of Edinburgh and NHS Lothian Health Board
Eligibility
Sex/Gender
All
Age
60 Years to 110 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 03/07/2025: Death or major cardiac adverse events (MACE) or new MINS measured using patient records up to 30 days _____ Previous primary outcome measure: Death or major cardiac adverse events (MACE) measured using patient records up to 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records at 30 days: 1. All cause mortality 2. Myocardial injury post randomisation (troponin >99th centile (URL) AND a 20% change from baseline) 3. Individual MACE components 4. Complications (including AKI, delirium, stroke, pulmonary embolus) 5. Proportion of participants transfused 6. Discharge destination 7. Acute hospital length of stay 8. EQ-5D-5L9. Health services resource utilisation (from questionnaires) Additional secondary outcome measures Measured using patient records at 120 days: 1. All cause mortality 2. Discharge destination 3. Acute hospital length of stay 4. unplanned hospital readmissions 5. Mobility 6. Residential status 7. EQ-5D-5L9., Health services resource utilisation (from questionnaire) | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed