(FROM THE APPLICATION): Over 11 million units are transfused in the United States. Despite the common use of red blood cell transfusions, the threshold for transfusion has not been adequately evaluated. A decade ago the standard of care was to administer a peri-operative transfusion whenever the hemoglobin level fell below 10 g/dl (the """"""""10/30 rule""""""""). Concerns about the safety of blood, especially with respect to HIV and hepatitis, and the absence of data to support a 10 g/dl threshold led to current standard of care to administer blood transfusions based on the presence of symptoms and not a specific hemoglobin/hematocrit level. However, there are no randomized clinical trials in surgical patients that have tested the efficacy and safety of withholding blood until the patient develops symptoms or the 10/30 approach to transfusion and limited evidence for patients with underlying cardiovascular disease are at greatest risk of adverse effects from reduced hemoglobin levels. We propose to conduct a multi-center randomized trial to test if a more aggressive transfusion strategy that maintains postoperative hemoglobin levels above 10 g/dl improves patient outcome as compared to a more conservative strategy that withholds blood transfusion until the patient develops symptoms of anemia. Patients eligible for the trial will have undergone surgical repair for a hip fracture and have a postoperative hemoglobin level below 10 g/dl within three days of surgery. Only patients with cardiovascular disease will be entered into the study. Symptomatic transfusion strategy patients will receive red blood cell transfusions for symptoms of anemia, although transfusion is also permitted but not required if the hemoglobin level falls below 8 g/dl. Outcomes will include functional recovery (primary outcome: ability to walk ten feet across a room without human assistance at 60-days post-randomization), long-term survival, nursing home placement, and postoperative complications (death in hospital or within 30 days, pneumonia, myocardial infarction, thromboembolism, stroke). We will randomize 2,600 patients over a 3.5-year period to detect a reduction in the loss of ability to walk independently from 43% to 36% (16% relative risk reduction) with power about 0.90. Also, this study will measure the frequency and 95% confidence intervals of the medical errors that are important in this patient population. The medical errors that will be measured are: transfusion errors (blood transfusion to the wrong patient, mislabeling of samples for type and cross match, use of whole blood instead of packed red cells), failure to use thromboembolism prophylaxis, incorrect antibiotic prophylaxis, wrong site surgery, and femoral shaft fracture.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL074815-04
Application #
6917257
Study Section
Special Emphasis Panel (ZAG1-DAG-7 (J2))
Program Officer
Barbosa, Luiz H
Project Start
2003-07-10
Project End
2008-06-30
Budget Start
2005-07-01
Budget End
2006-06-30
Support Year
4
Fiscal Year
2005
Total Cost
$441,748
Indirect Cost
Name
University of Maryland Baltimore
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
Beaupre, Lauren A; Carson, Jeffrey L; Noveck, Helaine et al. (2015) Recovery of Walking Ability and Return to Community Living within 60 Days of Hip Fracture Does Not Differ Between Male and Female Survivors. J Am Geriatr Soc 63:1640-4
Carson, Jeffrey L; Sieber, Frederick; Cook, Donald Richard et al. (2015) Liberal versus restrictive blood transfusion strategy: 3-year survival and cause of death results from the FOCUS randomised controlled trial. Lancet 385:1183-9
Albrecht, Jennifer S; Marcantonio, Edward R; Roffey, Darren M et al. (2015) Stability of postoperative delirium psychomotor subtypes in individuals with hip fracture. J Am Geriatr Soc 63:970-6
Gruber-Baldini, Ann L; Marcantonio, Edward; Orwig, Denise et al. (2013) Delirium outcomes in a randomized trial of blood transfusion thresholds in hospitalized older adults with hip fracture. J Am Geriatr Soc 61:1286-95
Carson, Jeffrey L; Terrin, Michael L; Noveck, Helaine et al. (2011) Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med 365:2453-62
Carson, Jeffrey L; Terrin, Michael L; Magaziner, Jay et al. (2006) Transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS). Transfusion 46:2192-206