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Prolonged red blood cell storage not linked to poorer transfusion outcomes
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ORLANDO, Fla. — Red blood cells stored for a prolonged period appeared to deliver oxygen during and after blood transfusion as well as those stored for shorter periods, according to study results presented at the ASH Annual Meeting and Exposition.
“Blood is an essential medicine and blood transfusion is one of the most commonly performed procedures in the world,” Christine M. Cserti-Gazdewich, MD, FRCPC, assistant professor of medicine and transfusion medicine specialist at University of Toronto, told HemOnc Today. “Concerns have been raised on the detrimental effects of red blood cell storage, which is permitted to span up to 6 weeks with current additive and preservative solutions, for the risks and benefits at the extreme ends of legal shelf life.”
During storage, red blood cells undergo structural, biochemical and enzymatic changes that may impair the ability of erythrocytes to deliver oxygen to tissues and may contribute to adverse outcomes.
“Red blood cell shortfalls exist in less developed countries and may worsen if storage durations are progressively narrowed,” Cserti-Gazdewich said. “Randomized controlled trials addressing ‘staleness paranoia’ have shown no harm from ‘non-fresh’ blood, but these studies have been run in patients who received red blood cells that were not necessarily needed, not assessed for the blood’s positive performance impact or not entirely distinct in the two storage arms.”
Thus, Cserti-Gazdewich and colleagues initiated a prospective, randomized controlled trial to compare short storage vs. longer storage of red blood cells with regard to tissue oxygen delivery, measured by the reduction in blood lactate levels in patients with severe anemia.
The study included data from 290 pediatric patients (age range, 6 months to 5 years) who presented at a university hospital urgent care facility with hemoglobin levels at or less than 5 g/dL and associated lactate levels at or greater than 5 mM.
All patients had lactic acidosis caused by severe anemia, but did not have shock, trauma, impaired cardiac function, refractory hypoxia, liver disease or tissue injury.
The researchers randomly assigned the children to receive leukoreduced red blood cells stored for 1 to 10 days (n = 145) or 25 to 35 days (n = 145). All patients received 10 mL/kg of red blood cells during the first 2 hours of treatment, with an additional 10 mL/kg during hours 4 through 6 if indicated per protocol.
The proportion of patients achieving a lactate level less than or equal to 3 mM at 8 hours served as the primary endpoint. The researchers measured blood lactate levels at 0, 2, 4, 6, 8 and 24 hours following transfusion.
At presentation, patients had a mean hemoglobin level of 3.7 ± 1.3 g/dL and a mean lactate level of 9.3 ± 3.4 mM.
The average duration of storage was 7.8 ± 2.1 days in the shorter-storage arm and 31.6 ± 2.8 days in the longer-storage arm.
The proportion of patients in the longer-storage vs. shorter-storage arms who achieved the target mean lactate level met the study’s noninferiority threshold (shorter-storage = 0.58; 95% CI, 0.49-0.66; longer-storage = 0.61; 95% CI, 0.52-0.69).
Further, mean lactate levels did not significantly differ between the two arms during any time point.
The researchers further noted that clinical assessment, serial measurements of hemoglobin concentration, cerebral tissue oxygen saturation and electrolyte abnormalities improved to the same degree in both groups following transfusion, and that adverse events, OS and 30-day recovery did not significantly differ.
In a prespecified subgroup analysis, patients who received 20 mL/kg of red blood cells did not experience any significant differences in outcomes.
“Our work strongly complements the randomized controlled trial work that has already been performed elsewhere in the world, bringing increasingly generalizable proof that storage is not the demon some imagine it to be,” Cserti-Gazdewich said in an interview. “We are looking deeply at our storage arms for any more subtle differences in the clinical and laboratory effects of blood transfusion in our recipients, such as heart strain and more direct measures of tissue oxygenation by our use of newer, noninvasive technologies.”
These study results were simultaneously published in JAMA, along with an accompanying editorial written by Philip C. Spinella, MD, FCCM, associate professor of pediatrics at Washington University in St. Louis, and Jason Acker, MBA, PhD, associate professor of laboratory medicine and pathology at University of Alberta, Edmonton, and senior scientist with Canadian Blood Services.
In their editorial, Spinella and Acker highlighted the need for better data collection to facilitate more comprehensive research in this area of study.
“Currently, most health care systems do not collect and analyze data that would allow for improvement in transfusion-related outcomes,” Spinella and Acker wrote. “More complete data throughout the continuum from donation to transfusion are needed to improve outcomes for patients requiring transfusions.”
These data can be derived from blood collection centers and hospital blood banks, they added.
“Hospitals should collect data on patients receiving transfusions, the indications for transfusion, the timing and dose of each blood product transfused, and the physiologic response to transfusion,” they wrote. “Administrative data sets need to be linked to each of these data sets to allow cost-effective analyses to be performed. Only with better data can future studies determine which therapies or strategies are optimal to improve outcomes for patients requiring transfusions.” – by Cameron Kelsall
References:
Dhabangi A, et al. Abstract 769. Presented at: ASH Annual Meeting and Exposition; Dec. 5-8, 2015; Orlando, Fla.
Dhabangi A, et al. JAMA. 2015;doi:10.1001/jama.2015.13977.
Spinella PC, Acker J. JAMA. 2015;doi:10.1001/jama.2015.14714.
For more information:
Christine M. Cserti-Gazdewich, MD, FRCPC, can be reached at Toronto General Hospital Blood Transfusion Laboratory, 200 Elizabeth St., Room3EC-306, Toronto, ON M5G 2C4; email: christine.cserti@uhn.ca.
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Mark Crowther, MD, MSc, FRCPC
The outcomes of this study may influence global health policy decisions regarding the acceptable duration of blood storage worldwide. This is a crushingly urgent problem. There has been a belief system that older blood is not as good for you as newer blood, without any real evidence to support that. Cserti-Gazdewich and colleagues present some really compelling evidence that that hypothesis may be incorrect.
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