Gruber‐Baldini 2013.
Study characteristics | ||
Methods | Design: RCT of liberal blood transfusion thresholds compared to restrictive transfusion practice for hip fracture patients Date of study: April 2008‐February 2009 Power calculation: yes Frequency of outcomes assessment: multiple times within 5 days after randomisation or up to hospital discharge (if hospital stay was shorter) Inclusion criteria: aged 50 and older; undergoing surgical repair of hip fracture; Hb < 10 g/dL within 3 days after surgery; clinical evidence of cardiovascular disease or cardiovascular disease risk factors Exclusion criteria: non‐English speaking; unable to walk unaided before fracture; declined blood transfusions; multiple traumas; pathological hip fracture; clinical acute myocardial infarction within 30 days pre‐randomisation; previous participants in the trial; symptoms associated with anaemia; actively bleeding at time of potential randomisation |
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Participants | Number in study: 139 Country: USA and Canada Setting: 13 hospitals Age: mean age 82.4 (SD 7.4) in intervention group compared to 80.6 (SD 10.4) in control group Sex: 81.8% of intervention group were female compared to 47% of control group Co‐morbidity: numbers and percentages of common co‐morbidities reported in paper (stroke/TIA, chronic lung disease, cancer, diabetes, atrial fibrillation, Parkinson's disease, hearing problems, visual problems and alcohol abuse or withdrawal) Dementia: 27.3% of intervention group had dementia compared to 36.1% of the control group Frailty: not reported |
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Interventions | Intervention (aka liberal treatment): one unit of packed red blood cells and as much blood as needed to maintain a Hb concentration >10 g/dL Control (aka restrictive treatment): only transfused if symptoms of anaemia developed or at the study physicians discretion or if Hb < 8 g/dL |
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Outcomes | Outcomes reported: ‐ Incident delirium, using CAM ‐ Delirium severity, using MDAS ‐ Length of admission ‐ Physical morbidity (post‐randomisation adverse events) ‐ Psychoactive medication use Outcomes from study not reported: none Frequency of outcomes assessment: multiple times within 5 days after randomisation or up to hospital discharge. |
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Notes | Funding source: Research grant from National Heart Lung and Blood Institute Declarations of interest: quote: "Dr Magaziner received support from Amgen, Eli Lilly, Glaxo SmithKline, Merck, Novartis and Sanofi Aventis to conduct research through his institution, provide academic consultation, or serve on an advisory board. Dr Roffey reports working as a consultant for Palladian Health. Dr Cardson reports receiving grant support to his institution from Amgen. Dr Marcantionio is a recipient of a Mid‐Career Investigator Award in Patient‐Oriented Research from the National Institute on Aging" Delirium assessed at baseline but not excluded >1/3 of the restrictive group received transfusion |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Automated central telephone randomisation system |
Allocation concealment (selection bias) | Low risk | No evidence to suggest allocations revealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Research staff unblinded to treatment status except at one site |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 139 randomised, outcome assessment data available for 138 |
Selective reporting (reporting bias) | Low risk | Data reported for all participants included in the study |
Other bias | Low risk | No evidence of other bias |