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

Publication ,  Journal Article
DeBaun, MR; Gordon, M; McKinstry, RC; Noetzel, MJ; White, DA; Sarnaik, SA; Meier, ER; Howard, TH; Majumdar, S; Inusa, BPD; Telfer, PT; Fuh, BR ...
Published in: N Engl J Med
August 21, 2014

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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 21, 2014

Volume

371

Issue

8

Start / End Page

699 / 710

Location

United States

Related Subject Headings

  • Transfusion Reaction
  • Single-Blind Method
  • Secondary Prevention
  • Male
  • Intention to Treat Analysis
  • Intelligence
  • Humans
  • Hemoglobin, Sickle
  • General & Internal Medicine
  • Ferritins
 

Citation

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DeBaun, M. R., Gordon, M., McKinstry, R. C., Noetzel, M. J., White, D. A., Sarnaik, S. A., … Casella, J. F. (2014). Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia. N Engl J Med, 371(8), 699–710. https://doi.org/10.1056/NEJMoa1401731
DeBaun, Michael R., Mae Gordon, Robert C. McKinstry, Michael J. Noetzel, Desiree A. White, Sharada A. Sarnaik, Emily R. Meier, et al. “Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia.N Engl J Med 371, no. 8 (August 21, 2014): 699–710. https://doi.org/10.1056/NEJMoa1401731.
DeBaun MR, Gordon M, McKinstry RC, Noetzel MJ, White DA, Sarnaik SA, et al. Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia. N Engl J Med. 2014 Aug 21;371(8):699–710.
DeBaun, Michael R., et al. “Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia.N Engl J Med, vol. 371, no. 8, Aug. 2014, pp. 699–710. Pubmed, doi:10.1056/NEJMoa1401731.
DeBaun MR, Gordon M, McKinstry RC, Noetzel MJ, White DA, Sarnaik SA, Meier ER, Howard TH, Majumdar S, Inusa BPD, Telfer PT, Kirby-Allen M, McCavit TL, Kamdem A, Airewele G, Woods GM, Berman B, Panepinto JA, Fuh BR, Kwiatkowski JL, King AA, Fixler JM, Rhodes MM, Thompson AA, Heiny ME, Redding-Lallinger RC, Kirkham FJ, Dixon N, Gonzalez CE, Kalinyak KA, Quinn CT, Strouse JJ, Miller JP, Lehmann H, Kraut MA, Ball WS, Hirtz D, Casella JF. Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia. N Engl J Med. 2014 Aug 21;371(8):699–710.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

August 21, 2014

Volume

371

Issue

8

Start / End Page

699 / 710

Location

United States

Related Subject Headings

  • Transfusion Reaction
  • Single-Blind Method
  • Secondary Prevention
  • Male
  • Intention to Treat Analysis
  • Intelligence
  • Humans
  • Hemoglobin, Sickle
  • General & Internal Medicine
  • Ferritins