FOCUS Hip Fracture Transfusion Trial: Delirium and Other Cognitive Outcomes
Principal Investigator: Ann Gruber Baldini
Affiliation: University of Maryland
Abstract: Proposed is an ancillary study to the Transfusion Therapy Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) to examine the impact of the hemoglobin interventions on delirium in a sub-sample of 200 subjects (100 per randomization group). FOCUS is a randomized clinical trial of 2,000 hip fracture patients funded by the NHLBI designed to test the hypothesis that a higher blood transfusion threshold does not improve functional recovery or reduce morbidity and mortality. Patients are randomized to receive enough blood to maintain hemoglobin level >10 g/dL versus receiving transfusion if hemoglobin level is less than 8 g/dL or when symptoms of anemia develop (symptomatic strategy). This ancillary study will extend our understanding the effects of transfusion thresholds on delirium. The primary aims are to determine whether a symptomatic transfusion strategy (8 g/dL) is associated with more severe symptoms of acute delirium during hospitalization compared to a 10 g/dL transfusion strategy. Secondary aims will examine whether the transfusion randomization also affects persistence of delirium symptoms at 30 days post-discharge and will examine the association of in hospital and 30-day persistence of delirium symptoms on later functional outcomes. The 200 subjects will be recruited from 16 FOCUS sites. FOCUS subjects are hip fracture patients, ages 50+, with a history of CVD or cardiovascular risk factors, and who have a post-operative hemoglobin level less than 10 g/dL within 3 days of surgery. Subjects will be assessed for delirium pre- randomization, for up to 3 days post-randomization (in-hospital), and at 30 days post-randomization. Outcomes include 30- and 60-day morbidity, mortality, lower extremity function, instrumental activities of daily living, and discharge location. Our sample size projections seek to detect medium effects. Generalized Estimation Equations will be used to evaluate the longitudinal patterns between the two groups of 100 hip fracture patients using all measurement time points. Intention to treat principles will be followed in the analyses. Analyses will be done by randomization group, and sensitivity analyses will examine whether there are differences in important confounders between groups and their effects on the analyses. PERFORMANCE SITE(S): University of Maryland Baltimore, Baltimore, MD University of Medicine and Dentistry of New Jersey, New Brunswick, NJ Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA Baltimore Research &Education Foundation, Perry Point, MD Clinical Sites: Robert Wood Johnson Hospital, New Brunswick, NJ London Health Science Center, Toronto, Canada Mayo Clinic, St. Mary's Hospital, Rochester, MI Sunny Brook, Toronto, Canada Johns Hopkins Bayview Medical Center, Baltimore MD Cooper University Hospital, Camden, NJ University of Ottowa, Ottowa, Canada Eastern Virginia Medical School, Norfolk, VA Columbia University Medical Center, New York, NY New York Presbyterian Hospital, New York, NY Cleveland Clinic, Cleveland, OH Lahey Clinic Medical Center, Burlington, MA Emory University, Atlanta, GA Texas Technical, Lubbock, TX Maimondes Medical Center, Brooklyn, NY University of British Columbia, Vancouver, Canada This is an ancillary study to a large clinical trial (R01 HL073958) that looks at different levels of blood transfusion to treat blood loss after hip fracture surgery, in patients who also have cardiovascular disease or cardiovascular risk factors. This ancillary study examines whether transfusion helps prevent short-term (post- randomization) and long-term (30 day) changes in delirium.
Funding Period: ----------------2008 - ---------------2011-
more information: NIH RePORT