Fri., 10/15/10 Geriatrics, Paper #44, 10:40 am OTA-2010
Functional and Cardiac Outcomes Comparing Symptomatic versus 10 g/dL Transfusion Threshold: A Randomized Trial in over 2000 Patients with Hip Fracture
David W. Sanders, MD1; Jeffrey L. Carson, MD2; Michael L. Terrin, MD3;
Jay L. Magaziner, MD3; Courtland G. Lewis, MD1; Lauren Beaupre, MD4;
William McAuley, MD5; Kevin Hildebrand, MD6; FOCUS Investigators
1University of Western Ontario, London, Ontario, Canada;
2UMDNJ: New Jersey Medical School, Newark, New Jersey, USA;
3University of Maryland, College Park, Maryland, USA;
4University of Alberta, Edmonton, Alberta, Canada;
5Columbia University, Columbia, New York, USA;
6University of Calgary, Calgary, Alberta, Canada
Purpose: Postoperative anemia is common after hip fracture. The threshold at which transfusion is beneficial is controversial. The Transfusion Trigger Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) is a randomized controlled trial designed to determine whether higher blood transfusion thresholds improve functional recovery and reduce mortality and morbidity after hip fracture repair.
Methods: 2,016 patients 50 years of age or older who underwent surgery for hip fracture, had a history of or risk factors for cardiovascular disease, and had postoperative anemia (hemoglobin [Hgb] <10 g/dL) were randomized from 47 North American centers. Patients were randomly allocated to a transfusion threshold of 10 g/dL, or to receive transfusion when anemia symptoms occurred. Transfusion in the restrictive group was permitted but not required if Hgb level was <8 g/dL. Inhospital mortality, cardiac events, and complications (pneumonia, infection, heart failure, stroke, deep venous thrombosis/pulmonary embolism), and length of stay were compared between the groups. Functional outcome, defined as the ability to walk across a room without human assistance, was compared at 30 and 60 days.
Results: 2,016 patients were enrolled from 47 North American medical centers. The mean age of the study subjects was 81.6 ± 8.9 years, and 75.7 % were female. Fracture types included femoral neck fractures (841), intertrochanteric fractures (973), and subtrochanteric fractures (196); 6 fractures were not classified. Surgical treatment included arthroplasty (728 patients), extramedullary fixation (708 patients), and intramedullary fixation (424 patients). 141 patients had combined treatment strategies and 15 patients did not have the surgical procedure identified. The 1,007 patients in the liberal group were transfused a total of 1,866 units of blood for an average Hgb of 9.2 g/dL, while the 1009 patients in the restrictive group received a total of 652 units for an average Hgb of 7.9 g/dL. Inhospital outcomes including mortality, cardiac events, infection, and length of stay did not differ between the groups. The rates of death or inability to walk without human assistance at 60 days were similar between the two arms (P = 0.80). In the liberal (10 g/dL) group, 34.9% were dead or unable to walk without human assistance and for the symptomatic group 34.3%. The 30- and 60- day mortality rates were similar between the two arms of the trial.
Conclusions: A restrictive transfusion threshold had no adverse effects on functional outcome, cardiac events, or mortality in this high-risk group of elderly patients. Patients in the symptomatic arm of the trial received much less blood transfusion (65% fewer units) than the 10 g/dL group; 58.5% of patients in the symptomatic arm did not receive any blood transfusion. Widespread implementation of the symptomatic approach to transfusion in comparable patients would greatly reduce blood demands with no discernible effect on mortality or function.
Alphabetical Disclosure Listing (292K PDF)
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.