Design of the silent cerebral infarct transfusion (SIT) trial

James F. Casella, Allison A. King, Bruce Barton, Desiree A. White, Michael J. Noetzel, Rebecca N. Ichord, Cindy Terrill, Deborah Hirtz, Robert C. McKinstry, John J. Strouse, Thomas H. Howard, Thomas D. Coates, Caterina P. Minniti, Andrew D. Campbell, Bruce A. Vendt, Harold Lehmann, Michael R. Debaun

Research output: Contribution to journalArticle

76 Citations (Scopus)

Abstract

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, 1218 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.

Original languageEnglish (US)
Pages (from-to)69-89
Number of pages21
JournalPediatric Hematology and Oncology
Volume27
Issue number2
DOIs
StatePublished - 2010
Externally publishedYes

Fingerprint

Blood Transfusion
Sickle Cell Anemia
Magnetic Resonance Imaging
Morbidity
Neurologic Examination
Brain
Therapeutics
Child Care
Random Allocation
Stroke
Observation
DNA
Serum

Keywords

  • Blood transfusion therapy
  • Clinical trials
  • Hemoglobinopathies
  • Sickle cell anemia
  • Silent cerebral infarcts

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Hematology
  • Oncology

Cite this

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. Pediatric Hematology and Oncology, 27(2), 69-89. https://doi.org/10.3109/08880010903360367

Design of the silent cerebral infarct transfusion (SIT) trial. / Casella, James F.; King, Allison A.; Barton, Bruce; White, Desiree A.; Noetzel, Michael J.; Ichord, Rebecca N.; Terrill, Cindy; Hirtz, Deborah; McKinstry, Robert C.; Strouse, John J.; Howard, Thomas H.; Coates, Thomas D.; Minniti, Caterina P.; Campbell, Andrew D.; Vendt, Bruce A.; Lehmann, Harold; Debaun, Michael R.

In: Pediatric Hematology and Oncology, Vol. 27, No. 2, 2010, p. 69-89.

Research output: Contribution to journalArticle

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 2010, 'Design of the silent cerebral infarct transfusion (SIT) trial', Pediatric Hematology and Oncology, vol. 27, no. 2, pp. 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. Pediatric Hematology and Oncology. 2010;27(2):69-89. https://doi.org/10.3109/08880010903360367
Casella, James F. ; King, Allison A. ; Barton, Bruce ; White, Desiree A. ; Noetzel, Michael J. ; Ichord, Rebecca N. ; Terrill, Cindy ; Hirtz, Deborah ; McKinstry, Robert C. ; Strouse, John J. ; Howard, Thomas H. ; Coates, Thomas D. ; Minniti, Caterina P. ; Campbell, Andrew D. ; Vendt, Bruce A. ; Lehmann, Harold ; Debaun, Michael R. / Design of the silent cerebral infarct transfusion (SIT) trial. In: Pediatric Hematology and Oncology. 2010 ; Vol. 27, No. 2. pp. 69-89.
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AU - King, Allison A.

AU - Barton, Bruce

AU - White, Desiree A.

AU - Noetzel, Michael J.

AU - Ichord, Rebecca N.

AU - Terrill, Cindy

AU - Hirtz, Deborah

AU - McKinstry, Robert C.

AU - Strouse, John J.

AU - Howard, Thomas H.

AU - Coates, Thomas D.

AU - Minniti, Caterina P.

AU - Campbell, Andrew D.

AU - Vendt, Bruce A.

AU - Lehmann, Harold

AU - Debaun, Michael R.

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N2 - 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, 1218 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.

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