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Design of the silent cerebral infarct transfusion (SIT) trial.

Publication ,  Journal Article
Casella, JF; King, AA; Barton, B; White, DA; Noetzel, MJ; Ichord, RN; Terrill, C; Hirtz, D; McKinstry, RC; Strouse, JJ; Howard, TH; Coates, TD ...
Published in: Pediatr Hematol Oncol
March 2010

BACKGROUND: Silent cerebral infarct (SCI) is the most common cause of serious neurological disease in sickle cell anemia (SCA), affecting approximately 22% of children. The goal of this trial is to determine whether blood transfusion therapy will reduce further neurological morbidity in children with SCI, and if so, the magnitude of this benefit. PROCEDURE: The Silent Cerebral Infarct Transfusion (SIT) Trial includes 29 clinical sites and 3 subsites, a Clinical Coordinating Center, and a Statistical and Data Coordinating Center, to test the following hypothesis: prophylactic blood transfusion therapy in children with SCI will result in at least an 86% reduction in the rate of subsequent overt strokes or new or progressive cerebral infarcts as defined by magnetic resonance imaging (MRI) of the brain. The intervention is blood transfusion versus observation. Two hundred and four participants (102 in each treatment assignment) will ensure 85% power to detect the effect necessary to recommend transfusion therapy (86% reduction), after accounting for 10% drop out and 19% crossover rates. MRI examination of the brain is done at screening, immediately before randomization and study exit. Each randomly assigned participant receives a cognitive test battery at study entry, 12-18 months later, and study exit and an annual neurological examination. Blood is obtained from all screened participants for a biologic repository containing serum and a renewable source of DNA. CONCLUSION: The SIT Trial could lead to a change in standard care practices for children affected with SCA and SCI, with a consequent reduction in neurological morbidity.

Duke Scholars

Published In

Pediatr Hematol Oncol

DOI

EISSN

1521-0669

Publication Date

March 2010

Volume

27

Issue

2

Start / End Page

69 / 89

Location

England

Related Subject Headings

  • Stroke
  • Research Design
  • Oncology & Carcinogenesis
  • Magnetic Resonance Imaging
  • Humans
  • Child
  • Cerebral Infarction
  • Blood Transfusion
  • Anemia, Sickle Cell
  • 3201 Cardiovascular medicine and haematology
 

Citation

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Casella, J. F., King, A. A., Barton, B., White, D. A., Noetzel, M. J., Ichord, R. N., … Debaun, M. R. (2010). Design of the silent cerebral infarct transfusion (SIT) trial. Pediatr Hematol Oncol, 27(2), 69–89. https://doi.org/10.3109/08880010903360367
Casella, James F., Allison A. King, Bruce Barton, Desiree A. White, Michael J. Noetzel, Rebecca N. Ichord, Cindy Terrill, et al. “Design of the silent cerebral infarct transfusion (SIT) trial.Pediatr Hematol Oncol 27, no. 2 (March 2010): 69–89. https://doi.org/10.3109/08880010903360367.
Casella JF, King AA, Barton B, White DA, Noetzel MJ, Ichord RN, et al. Design of the silent cerebral infarct transfusion (SIT) trial. Pediatr Hematol Oncol. 2010 Mar;27(2):69–89.
Casella, James F., et al. “Design of the silent cerebral infarct transfusion (SIT) trial.Pediatr Hematol Oncol, vol. 27, no. 2, Mar. 2010, pp. 69–89. Pubmed, doi:10.3109/08880010903360367.
Casella JF, King AA, Barton B, White DA, Noetzel MJ, Ichord RN, Terrill C, Hirtz D, McKinstry RC, Strouse JJ, Howard TH, Coates TD, Minniti CP, Campbell AD, Vendt BA, Lehmann H, Debaun MR. Design of the silent cerebral infarct transfusion (SIT) trial. Pediatr Hematol Oncol. 2010 Mar;27(2):69–89.

Published In

Pediatr Hematol Oncol

DOI

EISSN

1521-0669

Publication Date

March 2010

Volume

27

Issue

2

Start / End Page

69 / 89

Location

England

Related Subject Headings

  • Stroke
  • Research Design
  • Oncology & Carcinogenesis
  • Magnetic Resonance Imaging
  • Humans
  • Child
  • Cerebral Infarction
  • Blood Transfusion
  • Anemia, Sickle Cell
  • 3201 Cardiovascular medicine and haematology