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Randomized Controlled Trial
. 2019 Dec 10;322(22):2179-2190.
doi: 10.1001/jama.2019.17478.

Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial

Philip C Spinella  1 , Marisa Tucci  2 , Dean A Fergusson  3 , Jacques Lacroix  2 , Paul C Hébert  4 , Stéphane Leteurtre  5 , Kenneth B Schechtman  6 , Allan Doctor  1 , Robert A Berg  7 , Tina Bockelmann  1 , J Jaime Caro  8   9 , Fabrizio Chiusolo  10 , Lucy Clayton  11 , Jill M Cholette  12 , Gonzalo Garcia Guerra  13   14 , Cassandra D Josephson  15   16 , Kusum Menon  17 , Jennifer A Muszynski  18 , Marianne E Nellis  19 , Amrita Sarpal  20 , Stephanie Schafer  1 , Marie E Steiner  21 , Alexis F Turgeon  22 ; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Réanimation et Urgences P
Collaborators, Affiliations
Randomized Controlled Trial

Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial

Philip C Spinella et al. JAMA. .

Abstract

Importance: The clinical consequences of red blood cell storage age for critically ill pediatric patients have not been examined in a large, randomized clinical trial.

Objective: To determine if the transfusion of fresh red blood cells (stored ≤7 days) reduced new or progressive multiple organ dysfunction syndrome compared with the use of standard-issue red blood cells in critically ill children.

Design, setting, and participants: The Age of Transfused Blood in Critically-Ill Children trial was an international, multicenter, blinded, randomized clinical trial, performed between February 2014 and November 2018 in 50 tertiary care centers. Pediatric patients between the ages of 3 days and 16 years were eligible if the first red blood cell transfusion was administered within 7 days of intensive care unit admission. A total of 15 568 patients were screened, and 13 308 were excluded.

Interventions: Patients were randomized to receive either fresh or standard-issue red blood cells. A total of 1538 patients were randomized with 768 patients in the fresh red blood cell group and 770 in the standard-issue group.

Main outcomes and measures: The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured for 28 days or to discharge or death.

Results: Among 1538 patients who were randomized, 1461 patients (95%) were included in the primary analysis (median age, 1.8 years; 47.3% girls), in which there were 728 patients randomized to the fresh red blood cell group and 733 to the standard-issue group. The median storage duration was 5 days (interquartile range [IQR], 4-6 days) in the fresh group vs 18 days (IQR, 12-25 days) in the standard-issue group (P < .001). There were no significant differences in new or progressive multiple organ dysfunction syndrome between fresh (147 of 728 [20.2%]) and standard-issue red blood cell groups (133 of 732 [18.2%]), with an unadjusted absolute risk difference of 2.0% (95% CI, -2.0% to 6.1%; P = .33). The prevalence of sepsis was 25.8% (160 of 619) in the fresh group and 25.3% (154 of 608) in the standard-issue group. The prevalence of acute respiratory distress syndrome was 6.6% (41 of 619) in the fresh group and 4.8% (29 of 608) in the standard-issue group. Intensive care unit mortality was 4.5% (33 of 728) in the fresh group vs 3.5 % (26 of 732) in the standard-issue group (P = .34).

Conclusions and relevance: Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells.

Trial registration: ClinicalTrials.gov Identifier: NCT01977547.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Spinella reported that he served as a consultant for Hemanext, that his institution received funding for the ABC PICU trial, has equity in KaloCyte, and received grants from KaloCyte, the National Heart, Lung, and Blood Institute (NHLBI), and the US Department of Defense (DOD). Dr Tucci reported that her institution received funding for the ABC-PICU trial. Dr Fergusson reported that his institution received funding data management and analysis for the ABC-PICU trial. Dr Lacroix reported that his institution received funding for the ABC-PICU trial. Dr Leteurtre reported that he received grants from Health French Ministry and GFRUP. Dr Schechtman reported that his institution received funding for the ABC-PICU trial. Dr Doctor reported that his institution received funding for the ABC-PICU trial; that he has equity in KaloCyte; received grants from KaloCyte, the National Institutes of Health (NIH), the NHLBI, the DOD, Entegrion; and that he received personal fees from Fresenius Kabi and Biogen. Dr Berg reported that she received grants from NIH. Ms Bockelmann reported that her institution received funding for the ABC-PICU trial. Dr Caro reported that he received support from Evidera and grants from EURO 2020. Ms Clayton reported that her institution received funding for the ABC-PICU trial. Dr Josephson reported that she has consulted for Octapharma and Immucor, received nonfinancial support from Sysmex, and received grants from Medtronics. Dr Muszynski reported that she received grants from the NIH. Ms Schafer reported that her institution received funding for the ABC-PICU trial. Dr Steiner reported that she received grants from NIH. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Screening, Randomization, and Follow-up in a Study of the Effect of Fresh vs Standard-issue Red Blood Cell Transfusions in Critically Ill Pediatric Patients
Patients were considered eligible for consent if they were admitted to pediatric intensive care unit (PICU) for an anticipated length of stay of more than 24 hours and if their first red blood cell transfusion was ordered during the first 7 days in PICU. aSome patients met more than 1 exclusion criterion. bAdherence to transfusion protocol was considered present if 80% or more of transfusions occurred with units stored for 7 days or less and if no units were stored for more than 14 days during the 28-day follow-up period. No crossover to the other study group occurred in either group. ECMO indicates extracorporeal membrane oxygenation.
Figure 2.
Figure 2.. Kaplan-Meier Analysis of Time to Development of New or Progressive Multiple Organ Dysfunction Syndrome
The primary analysis set of patients included 1460 patients. The hazard ratio in the fresh-blood group compared with the standard-issue group, was 1.12 (95% CI, 0.88 to 1.44; P = .34). For a definition of new and progressive multiple organ dysfunction syndrome and how it is categorized for this study, see the Methods section. PICU indicates pediatric intensive care unit. The median observation time until new or progressive multiple organ dysfunction was 5.0 days (95% CI, 2.0-10.0 days) in each study group.
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References

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