? ? FOCUS is a randomized clinical trial funded by the NHLBI designed to test the hypothesis that a higher blood transfusion threshold improves functional recovery and reduces morbidity and mortality. Patients who undergo surgery for hip fracture, have a history of cardiovascular disease, and have a postoperative hemoglobin (Hgb) level less than 10 g/dL within 3 days of surgery are eligible. Patients will be randomly assigned either to receive enough blood to raise the Hgb above 10 g/dL or to receive transfusion if symptoms of anemia develop; transfusion is permitted but not required if Hgb is less than 8 g/dL. The primary outcome is ability to walk 10 feet (or across a room) without human assistance at 60 days. ? ? A critical concern among clinicians is whether withholding transfusion in patients with perioperative anemia increases the risk of postoperative acute cardiac events. Recent observational studies have emphasized the importance of anemia and transfusion in the outcomes of patients with coronary artery disease. However, there has never been a randomized clinical trial that has evaluated the effect of transfusion thresholds on the postoperative risk of acute cardiac ischemic events, i.e. acute coronary syndromes, myocardial infarction. The current study protocol detects acute myocardial ischemic events such as myocardial infarction (Ml) by recording the results of cardiac biomarkers and electrocardiograms (ECG) obtained as part of usual clinical care. The goal of this new proposal is to support systematic detection of Ml. We recently obtained a non competing supplement that provides partial support for acquisition and storage of serum for cardiac troponin measurement and ECGs. Thus, we are currently collecting the necessary information and specimens for the diagnosis of Ml. This supplemental application seeks support for a Troponin Core Laboratory for measurement of troponin concentrations, and an ECG Core Laboratory to analyze the ECGs and to classify all postoperative acute coronary ischemic events. Resources are also requested to support continued collection of serum fortrooonin measurement and ECG's. ? ?

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HL073958-03S1
Application #
6962244
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Barbosa, Luiz H
Project Start
2003-09-01
Project End
2008-08-31
Budget Start
2005-09-01
Budget End
2006-08-31
Support Year
3
Fiscal Year
2005
Total Cost
$948,145
Indirect Cost
Name
University of Medicine & Dentistry of NJ
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
617022384
City
Piscataway
State
NJ
Country
United States
Zip Code
08854
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
Patel, Manish S; Carson, Jeffrey L (2009) Anemia in the preoperative patient. Med Clin North Am 93:1095-104
Patel, Manish S; Carson, Jeffrey L (2009) Anemia in the preoperative patient. Anesthesiol Clin 27:751-60
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