"Liberal or Restrictive Transfusion after Hip Fracture Surgery". The New England Journal of Medicine. 2011. 365(26):2453-2462. PubMed
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In elderly patients with known cardiovascular disease or risk factors undergoing surgery for hip fracture, does a liberal transfusion strategy improve recovery and reduce morbidity and mortality compared to a restrictive transfusion strategy?
In elderly patients with cardiovascular risk factors undergoing surgery for hip fracture, a liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently at 60-day follow-up and did not significantly reduce in-hospital morbidity.
The optimal threshold for postoperative blood transfusion in elderly patients at high cardiovascular risk is debated. The FOCUS trial aimed to determine whether a higher hemoglobin threshold for blood transfusion would improve outcomes in patients 50 years or older with cardiovascular disease or risk factors who had surgery for hip fracture.
At the time of publication, no updated guidelines reflecting the results of this trial were provided.
- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial - N=2,016 patients with recent hip fracture surgery and cardiovascular disease or risk factors - Liberal transfusion strategy (target hemoglobin of ≥10 g/dL; n=1,007) - Restrictive transfusion strategy (transfusions for anemia symptoms or hemoglobin <8 g/dL; n=1,009) - Setting: 47 clinical sites in the United States and Canada - Enrollment: 2004-2009 - Follow-up: 60 days - Analysis: Intention-to-treat - Primary outcome: Death or inability to walk 10 ft (or across a room) without human assistance at 60 days
Inclusion Criteria - Age ≥50 years - Underwent primary surgical repair of a hip fracture - Clinical evidence of or risk factors for cardiovascular disease - Hemoglobin level <10 g/dL within 3 days after surgery
Exclusion Criteria - Unable to walk without human assistance before hip fracture - Declined blood transfusions - Multiple trauma - Pathologic hip fracture associated with cancer - Acute myocardial infarction within 30 days before randomization - Participation in the trial with contralateral hip fracture - Active bleeding or symptoms associated with anemia at the time of potential randomization
- Liberal-strategy group: 1 unit of packed red cells and additional blood transfused to maintain a hemoglobin level of ≥10 g/dL. - Restrictive-strategy group: Transfusions permitted if symptoms of anemia developed or hemoglobin fell below 8 g/dL.
Primary Outcome - Death or inability to walk without human assistance at 60-day follow-up: 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio 1.01; 95% CI, 0.84 to 1.22; P=0.90)
- In-hospital acute myocardial infarction, unstable angina or death: 4.3% liberal-strategy vs. 5.2% restrictive-strategy (P not significant) - Death on 60-day follow-up: 7.6% liberal-strategy vs. 6.6% restrictive-strategy (P not significant) - Length of hospital stay, scores for physical activities of daily living, instrumental activities of daily living, and fatigue were similar between groups. - Rates of residing at home at 30-day and 60-day follow-up were similar between groups.
Criticism - Telephone ascertainment of functional outcomes may be subject to miscommunication and poorly informed proxy respondents. - Walking ability and functional measure scores were not validated and were not useful for analysis for a substantial percentage of patients.
- Supported in part by grants from the National Heart, Lung, and Blood Institute.
- FOCUS ClinicalTrials.gov number, NCT00071032.