FOCUS
Trial question
What is the role of liberal transfusion strategy in high-risk patients after hip surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
76.0% female
24.0% male
N = 2016
2016 patients (1527 female, 489 male).
Inclusion criteria: patients ≥ 50 years of age with a history of or risk factors for CVD who had hemoglobin level < 10 g/dL after hip-fracture surgery.
Key exclusion criteria: unable to walk without human assistance before hip fracture, declined blood transfusions, had multiple trauma, pathologic hip fracture associated with cancer, history of clinically recognized acute MI within 30 days before randomization, or actively bleeding at the time of potential randomization.
Interventions
N=1007 liberal use of transfusions (a hemoglobin threshold of 10 g/dL).
N=1009 restrictive use of transfusion (symptoms of anemia or at physician discretion for a hemoglobin level of < 8 g/dL).
Primary outcome
Death or an inability to walk across a room without human assistance at 60 days
35.2%
34.7%
35.2 %
26.4 %
17.6 %
8.8 %
0.0 %
Liberal use of
transfusions
Restrictive use of
transfusion
No significant
difference ↔
No significant difference in death or an inability to walk across a room without human assistance at 60 days (35.2% vs. 34.7%; OR 1.01, 95% CI 0.84 to 1.22).
Secondary outcomes
No significant difference in in-hospital acute coronary syndrome or death (4.3% vs. 5.2%; OR 0.82, 99% CI 0.48 to 1.42).
No significant difference in death at 60 days (7.6% vs. 6.6%; OR 1.17, 99% CI 0.75 to 1.83).
Safety outcomes
No significant difference in serious adverse events and in-hospital clinical events.
Conclusion
In patients ≥ 50 years of age with a history of or risk factors for CVD who had hemoglobin level < 10 g/dL after hip-fracture surgery, liberal use of transfusions were not superior to restrictive use of transfusion with respect to death or an inability to walk across a room without human assistance at 60 days.
Reference
Carson JL, Terrin ML, Noveck H et al. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62.
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