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Wednesday, April 8, 2015
No evidence to change current transfusion practices for adults undergoing complex cardiac surgery
A National Institutes of Health-funded study found no statistical difference in the primary clinical measure — which assessed changes in function of six organs from before to seven days after surgery — between complex cardiac surgery patients receiving transfusions of red blood cell units stored for short (up to 10 days) versus long (21 or more days) periods. These findings indicate there is no need to alter how hospitals currently transfuse blood in adults going through complex cardiac surgical procedures.
Results of the Red Cell Storage Duration Study (RECESS), supported by the NIH’s National Heart, Lung, and Blood Institute (NHLBI), appear today in the New England Journal of Medicine.
In the United States, red blood cell units can be stored up to 42 days after collection. Basic research has documented changes in red blood cell units the longer that they are stored. Some studies, primarily observational, have found an association between the transfusion of blood stored for a longer duration and increased morbidity and mortality. However, the clinical significance of these findings is difficult to determine due to study-design limitations.
RECESS was a multicenter trial conducted at more than two dozen U.S. hospitals from January 2010 to January 2014 by the NHLBI-funded Transfusion Medicine and Hemostasis Clinical Trial Network (TMH CTN). The TMH CTN includes 17 core clinical centers and a data coordinating center. Patients were enrolled at most TMH CTN core clinical centers and some non-network centers.
RECESS evaluated 1,098 cardiac surgery patients who were randomized to receive red blood cell units stored for short or long periods. Patients in the longer storage period group received their transfusions using current care practices.
There was no statistical difference in the change in the primary clinical measure, the Multiple Organ Dysfunction Score (MODS), or mortality from before cardiac surgery to seven or 28 days after the operation for both transfusion groups. The MODS was evaluated because it is an objective and validated way to assess small changes in six organ systems, which includes respiratory, renal, hepatic, cardiovascular, hematologic and neurologic. There were no statistical differences in the mean number of serious and non-serious adverse events between the two groups.
“RECESS contributes to a long-standing question about whether red blood cell storage duration impacts a patient’s clinical outcome after transfusion.” said Keith Hoots, M.D., director of the NHLBI Division of Blood Diseases and Resources. “These findings are reassuring because they do not support the need to modify transfusion practices in adult patients undergoing complex cardiac surgery. In particular, there does not appear to be something gained by only transfusing red blood products stored for ten days or less.”
Because very few RECESS patients were under 18 years of age, findings primarily apply to adult patients undergoing complex cardiac surgery.
Centers that Participated in RECESS
TMH CTN Core Clinical Centers
- BloodCenter of Wisconsin, Milwaukee
- Children’s Hospital, Boston
- Weill Cornell Medical College, Cornell University, New York City
- Duke University, Durham, North Carolina
- Emory University, Atlanta
- Johns Hopkins Hospital, Baltimore
- Massachusetts General Hospital, Boston
- Puget Sound Blood Center, Seattle
- University of Iowa, Iowa City
- University of Maryland, Baltimore
- University of Minnesota, Minneapolis
- University of North Carolina, Chapel Hill
- University of Oklahoma Health Sciences Center, Oklahoma City/UT Southwestern Medical Center, Dallas
- University of Pittsburgh
TMH CTN Data Coordinating Center
- New England Research Institutes, Watertown, Massachusetts
- Mayo Clinic, Rochester, Minnesota
- Vanderbilt University, Nashville, Tennessee
- Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
- St. Luke’s Episcopal — Texas Heart Institute, Houston
- Baystate Medical Center, Springfield, Massachusetts
- Indiana/Ohio Heart, Fort Wayne, Indiana
- Indiana/Ohio Heart, St. Joseph Hospital, Fort Wayne, Indiana
- University of Florida, Gainesville
- St. Elizabeth’s Medical Center, Brighton, Massachusetts,
- Newark Beth Israel Medical Center, New Jersey
- Aspirus Heart and Vascular Institute, Wausau, Wisconsin
- Sanford Heart Center, Fargo, North Dakota
- Columbia University Medical Center, New York City
The National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, and sleep disorders. More information about NHLBI is available at http://www.nhlbi.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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- TMH CTN Home Page: http://www.tmhnetwork.org
- Clinical Trials.gov RECESS page: https://clinicaltrials.gov/ct2/show/NCT00991341