Methods | Randomised, unblinded, parallel, 2-group multicentre trial | |
Participants | Patients 50 years or older, who are undergoing surgical repair of a hip fracture, with Hb concentrations below 10.0 g/dL within 3 days after surgery and who have clinical evidence for cardiovascular disease or cardiovascular risk factors Sample size = 2016 | |
Interventions |
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Outcomes | Primary outcome is inability to walk 10 feet (or across a room) without human assistance or death prior to closure of the window for the 60-day, 30 and 60-day mortality. Other outcomes are Hb concentration, acute coronary syndrome (ACS), in-hospital myocardial infarction, unstable angina or death, disposition on discharge, survival, functional measures, fatigue/energy, readmission to hospital, pneumonia, wound infection, thromboembolism, stroke or transient ischaemic attack | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Data Co-ordinating Center staff prepared randomisation schedules for each site using randomly ordered block sizes of 2, 4, 6 or 8 |
Allocation concealment (selection bias) | Low risk | Used an automated telephone randomisation system |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | After random allocation, clinical site staff, clinicians and patients were not blinded to treatment assignment. Primary and secondary outcomes were assessed blinded to treatment assignment |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Intention-to-treat analysis |
Selective reporting (reporting bias) | Low risk | - |
Other bias | Low risk | - |