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Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia.

ABSTRACT: BACKGROUND:Silent cerebral infarcts are the most common neurologic injury in children with sickle cell anemia and are associated with the recurrence of an infarct (stroke or silent cerebral infarct). We tested the hypothesis that the incidence of the recurrence of an infarct would be lower among children who underwent regular blood-transfusion therapy than among those who received standard care. METHODS:In this randomized, single-blind clinical trial, we randomly assigned children with sickle cell anemia to receive regular blood transfusions (transfusion group) or standard care (observation group). Participants were between 5 and 15 years of age, with no history of stroke and with one or more silent cerebral infarcts on magnetic resonance imaging and a neurologic examination showing no abnormalities corresponding to these lesions. The primary end point was the recurrence of an infarct, defined as a stroke or a new or enlarged silent cerebral infarct. RESULTS:A total of 196 children (mean age, 10 years) were randomly assigned to the observation or transfusion group and were followed for a median of 3 years. In the transfusion group, 6 of 99 children (6%) had an end-point event (1 had a stroke, and 5 had new or enlarged silent cerebral infarcts). In the observation group, 14 of 97 children (14%) had an end-point event (7 had strokes, and 7 had new or enlarged silent cerebral infarcts). The incidence of the primary end point in the transfusion and observation groups was 2.0 and 4.8 events, respectively, per 100 years at risk, corresponding to an incidence rate ratio of 0.41 (95% confidence interval, 0.12 to 0.99; P=0.04). CONCLUSIONS:Regular blood-transfusion therapy significantly reduced the incidence of the recurrence of cerebral infarct in children with sickle cell anemia. (Funded by the National Institute of Neurological Disorders and Stroke and others; Silent Cerebral Infarct Multi-Center Clinical Trial ClinicalTrials.gov number, NCT00072761, and Current Controlled Trials number, ISRCTN52713285.).

SUBMITTER: DeBaun MR

PROVIDER: S-EPMC4195437 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia.

DeBaun Michael R MR Gordon Mae M McKinstry Robert C RC Noetzel Michael J MJ White Desiree A DA Sarnaik Sharada A SA Meier Emily R ER Howard Thomas H TH Majumdar Suvankar S Inusa Baba P D BP Telfer Paul T PT Kirby-Allen Melanie M McCavit Timothy L TL Kamdem Annie A Airewele Gladstone G Woods Gerald M GM Berman Brian B Panepinto Julie A JA Fuh Beng R BR Kwiatkowski Janet L JL King Allison A AA Fixler Jason M JM Rhodes Melissa M MM Thompson Alexis A AA Heiny Mark E ME Redding-Lallinger Rupa C RC Kirkham Fenella J FJ Dixon Natalia N Gonzalez Corina E CE Kalinyak Karen A KA Quinn Charles T CT Strouse John J JJ Miller J Philip JP Lehmann Harold H Kraut Michael A MA Ball William S WS Hirtz Deborah D Casella James F JF

The New England journal of medicine 20140801 8

<h4>Background</h4>Silent cerebral infarcts are the most common neurologic injury in children with sickle cell anemia and are associated with the recurrence of an infarct (stroke or silent cerebral infarct). We tested the hypothesis that the incidence of the recurrence of an infarct would be lower among children who underwent regular blood-transfusion therapy than among those who received standard care.<h4>Methods</h4>In this randomized, single-blind clinical trial, we randomly assigned children ...[more]

PMID: 25140956

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Project description:BACKGROUND:Blood transfusions are administered to children and adults with sickle cell anemia (SCA) for secondary stroke prevention, or as treatment for recurrent pain crises or acute anemia, but transfusion effects on cerebral hemodynamics and metabolism are not well-characterized. PURPOSE:To compare blood transfusion-induced changes in hemometabolic parameters, including oxygen extraction fraction (OEF) and cerebral blood flow (CBF), within and between adults and children with SCA. STUDY TYPE:Prospective, longitudinal study. SUBJECTS:Adults with SCA (n?=?16) receiving simple (n?=?7) or exchange (n?=?9) transfusions and children with SCA (n?=?11) receiving exchange transfusions were scanned once when hematocrit was near nadir and again within 7 days of transfusion. Adult controls without SCA or sickle trait (n?=?7) were scanned twice on separate days. FIELD STRENGTH/SEQUENCE:3.0T T1 -weighted, T2 -weighted, and T2 -relaxation-under-spin-tagging (TRUST) imaging, and phase contrast angiography. ASSESSMENT:Global OEF was computed as the relative difference between venous oxygenation (from TRUST) and arterial oxygenation (from pulse oximetry). Global CBF was computed as total blood flow to the brain normalized by intracranial tissue volume. STATISTICAL TESTS:Hemometabolic variables were compared using two-sided Wilcoxon signed-rank tests; associations were analyzed using two-sided Spearman's correlation testing. RESULTS:In adults with SCA, posttransfusion OEF?=?0.38?±?0.05 was lower (P?=?0.001) than pretransfusion OEF?=?0.45?±?0.09. A change in OEF was correlated with increases in hematocrit (P?=?0.02; rho?=?-0.62) and with pretransfusion hematocrit (P?=?0.02; rho?=?0.65). OEF changes after transfusion were greater (P?=?0.002) in adults receiving simple versus exchange transfusions. Posttransfusion CBF?=?77.7?±?26.4?ml/100g/min was not different (P?=?0.27) from pretransfusion CBF?=?82.3?±?30.2?ml/100g/min. In children with SCA, both posttransfusion OEF?=?0.28?±?0.04 and CBF?=?76.4?±?26.4 were lower than pretransfusion OEF?=?0.36?±?0.06 (P?=?0.004) and CBF?=?96.4?±?16.5 (P?=?0.004). DATA CONCLUSION:Cerebral OEF reduces following transfusions in adults and children with SCA. CBF reduces following transfusions more often in children compared to adults, indicating that vascular reserve capacity may remain near exhaustion posttransfusion in many adults. LEVEL OF EVIDENCE:2 Technical Efficacy Stage 5 J. Magn. Reson. Imaging 2019;49:466-477.

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Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia.

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Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia.

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