A randomised trial to investigate whether giving more blood transfusions to people undergoing surgery for hip fracture improves their outcomes

Not Applicable

• Conditions: Blood transfusion for recovery from hip surgery; Surgery

• Registration Number: ISRCTN28818784
• Lead Sponsor: niversity of Edinburgh and NHS Lothian Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-03
• Last Update Posted: 5 August 2024
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1964

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

Current participant inclusion 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 inclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death or major cardiac adverse events (MACE) measured using patient records up to 30 days

Secondary Outcome Measures

Name	Time	Method
Measured using patient records at 30 days:<br>1. All cause mortality<br>2. Myocardial injury post randomisation (troponin >99th centile (URL) AND a 20% change from baseline)<br>3. Individual MACE components<br>4. Complications (including AKI, delirium, stroke, pulmonary embolus)<br>5. Proportion of participants transfused<br>6. Discharge destination<br>7. Acute hospital length of stay<br>8. EQ-5D-5L9. Health services resource utilisation (from questionnaires)<br><br>Additional secondary outcome measures <br>Measured using patient records at 120 days:<br>1. All cause mortality <br>2. Discharge destination <br>3. Acute hospital length of stay <br>4. unplanned hospital readmissions<br>5. Mobility<br>6. Residential status<br>7. EQ-5D-5L9., Health services resource utilisation (from questionnaire)