FOCUS: Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair

This randomized clinical trial aims to determine whether a more aggressive transfusion strategy maintaining postoperative hemoglobin at 10 g/dL or higher is associated with improved function and a decreased risk of adverse postoperative events.

The study population includes 2600 patients aged 50 or older with a history of cardiovascular disease who are undergoing surgical repair of a fractured hip. Patients are eligible for the study if their Hgb level drops below 10 g/dL within the first three postoperative days and will be randomized to either 1) receive enough red blood cells to maintain their Hg level at or above 10g/dL or, 2) receive a red blood cell transfusion only in the presence of symptoms from anemia or if their Hgb is below 8 g/dL (transfusion is permitted, but not mandatory). Patients are contacted by telephone at 30 days and 60 days after surgery to determine vital status, ability to walk, and location of residence.

The results of this study will provide critical evidence to guide peri-operative transfusion status.

This study of 2600 patients is being conducted at several hospitals which include:

US sites:

Orlando Regional Medical Center - Orlando, Florida; University of Indiana - Indianapolis, Indiana; Mercy Medical Center - Des Moines, Iowa; Hospital for Special Surgery - New York, New York; University of Maryland - Baltimore, Maryland; Mary Immaculate Hospital - Queens, New York; Mayo Clinic - Rochester, Minnesota; Emory Hospital - Atlanta, Georgia; Wayne Memorial Hospital - North Carolina; Toms River Community Medical Center - Toms River, New Jersey; Botsford General Hospital - Farmington Hills, Minnesota; Hartford Hospital - Hartford, Connecticut; Robert Wood Johnson Medical School - New Brunswick, New Jersey; Mason City Clinic - Mason City, Iowa; Miriam Hospital - Rhode Island; DeKalb Medical Center - Decatur, Georgia; Jersey Shore Medical Center - Neptune, New Jersey; Johns Hopkins Bayview - Baltimore, Maryland; Lehigh Valley Hospital - Allentown, Pennsylvania; Columbia University Medical Center - New York, New York

Canadian sites:

University of Western Ontario - London, Ontario; Queens University - Kingston, Ontario; Rockyview General Hospital - Calgary, Alberta; Capital Health Research - Halifax, NS; Hospital Notre-Dame - Montreal, Quebec; St Michael's Hospital - Toronto, Ontario; Ottawa General Hospital - Ottawa, Ontario; Montreal University Hospital - Montreal, Quebec; Royal Columbian Hospital - New Westminster, British Columbia; Sunnybrook & Women's College- Toronto, Ontario; Royal Alexandria - Edmonton, Alberta