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Study ID 1004
Name Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial
Contact Email m.debaun@vumc.org
Acronym SIT Trial
Period 2004 - 2013
Design Clinical trial
Study PI Michael R. DeBaun
Institution Washington University School of Medicine
URL https://clinicaltrials.gov/ct2/show/NCT00072761
CTGovID https://clinicaltrials.gov/ct2/show/NCT00072761
Funding Agency NINDS
Grant Number 5U01NS042804-07
Overview The primary aim of this trial is to determine the effectiveness of blood transfusion therapy for the prevention of silent strokes in children with sickle cell anemia. This trial will also determine if blood transfusion therapy will prevent further cerebral injury and if the measured benefits of the therapy outweigh the risks associated with it.
Focus Areas 1. Changes in cognition, which were assessed bymeasurement of IQ scores with the Wechsler Abbreviated Scale of Intelligence12 or theWechsler Preschool and Primary Scale of Intelligence III
2. Scores on theBehavior Rating Inventory of Executive Function (BRIEF)
Outcomes Recurrence of infarct or hemorrhage as determined by neuroimaging, clinical evidence of permanent neurologic injury, or both. A new infarct had to meet the criteria for a silent cerebral infarction; an enlarged silent cerebral infarct was defined as a previously identified silent cerebral infarct that increased by at least 3 mm alongany linear dimension in any plane on MRI. A transient ischemic attack (TIA), which wasincluded in secondary analyses of neurologic outcomes, was defined as an event thatresulted in focal neurologic deficits that lasted less than 24 hours, did not result inabnormalities on T2-weighted or FLAIR images that were indicative of an acute infarct, andhad no other reasonable medical explanation.
Data Location Vanderbilt University Medical Center
Biospecimen Available Blood; Urine;
Data Consent Research team will only use and share information discussed in consent form, de-identified.
Biospecimen Consent By agreeing to participate, you authorize the use of your tissue for research that may benefit others.
Contact Consent NA
Genomic Data No
Age Range 0-99
No. Participants 196
Inclusion Criteria 1. Patient must have sickle cell anemia (hemoglobin SS) or sickle ß thalassemia (hemoglobin Sß-thal) as confirmed at the local institution by hemoglobin analysis after six months of age.
2. Patient must be 5 through 14 years of age (i.e., must have attained their 5th, but not their 15th birthday).
3. Informed consent with assent in accordance with the institutional policies (institutional IRB approval) and Federal guidelines (approved by the United States Department of Health and Human Services) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study.
4. Patient must have a silent cerebral infarct defined as a silent cerebral infarct like lesion on the study screening MRI based on consensus of opinion of two of three members of the neuroradiology committee and normal neurologic examination or a focal neurologic examination where the abnormality is inconsistent with neuroanatomical location. The neurologic examination will be done by the site neurologist and adjudicated by the neurology committee.
Exclusion Criteria 1. Patient with a history of a focal neurologic event lasting more than 24 hours with medical documentation or a history of prior overt stroke.
2. Patient with other neurological problems, such as neurofibromatosis, lead poisoning, non-febrile seizure disorder, or tuberous sclerosis.
3. Patient with HIV infection.
4. Pregnancy or lactating females.
5. Patient who received treatment with anti-sickling drugs or hydroxyurea within 3 months or anticipate receiving anti sickling drugs or hydroxyurea during the course of the study.
6. Patients on chronic blood transfusion therapy for other reasons.
7. Patient judged not likely to be compliant by his/her hematologist and study coordinator based on previous compliance in clinic appointments and following advice.
8. Patient unable to receive blood transfusion because of alloimmunization.
9. Patients who have or anticipate receiving permanent (or semi-permanent) metallic structures attached to their body. (e.g., braces on teeth, body piercings), which their physicians believe will interfere with the MRI of the head
10. Patients with any person living in the same household who have been randomly assigned in the SIT Trial.
11. Patients who have more than two standard care TCD studies with a TAMMV equal to or = 200 cm/sec by the non-imaging technique, or TAMX or equivalent =185 cm/sec for the imaging technique or a TCD that is indeterminate
12. Patients who have one standard care TCD study with a TAMMV equal to = 200 cm/sec by the non-imaging technique, or TAMX or equivalent =185 cm/sec for the imaging technique AND one standard care TCD study that is indeterminate
13. Patients whose pre-randomization MRI (2nd MRI immediately prior to randomization) show progressive silent infarct lesion
14. Patients with abnormal kidney function (creatinine > 2x upper limit of normal).
Study Documentation
  Select All 		Silent_Cerebral_Infarct_Transfusion_Trial_Manual_Procedures
Forms
  Select All 		   1. Screening_Eligibility_Form
   2. Consent_and_Assent_for_Screening
   3. Demographic_And_Phenotypic_Information
   4. Phlebotomy_And_Genomics_Form
   5. Transmittal_Biological_Samples
   6. Transcranial_Doppler_Tcd_Performance_Eefe
   7. Neurological_Consultant_Report
   8. Consent_And_Assent_For_Randomization
   9. Randomization_Eligibility_Form
   10. Headache_Event
   11. Epilepsy_InChildren_With_Sic
   12. NIH_Pediatric_Stroke_Scale_Su
   13. Interim_Medical_History
   14. Hematology_And_Physical_Exam
   15. Cognitive_Battery_Checklist
   16. Testing_Evaluation_Form
   17. Psychological_Test_Checklist_Wasi_Eccc
   18. Psychological_Test_Checklist_Brief_Dfdc
   19. Baseline_Laboratory_Form
   20. Serious_Adverse_Event_Report
   21. Adverse_Event_Reporting_NonC
   22. Infection_Complication
   23. Toxicity_Worksheet
   24. Report_Card
   25. CauseOfDeath_SITTrialAdHo
   26. Headache_Event_Neurologist
   27. Transfusion_Form
   28. TransfusionReactionForm_S
   29. Child_Health_Questionnaire_Transmittal_Form
   30. Hospitalization
   31. Chelation_Therapy_Complicat
   32. Additional_Siblings
   33. MRI_Failure
   34. Drop_During_Screening_Phase
   35. End_Point
   36. Missed_Form_Report
   37. Missed_Visit
   38. Central_VenousLine
   39. Consent_Questionnaire
   40. Phlebotomy_And_Proteomics_Form
   41. Transmittal_Of_Proteomics_Samples
   42. WithdrawalFormCompletedAf
   43. ChelatingAgents_SITTrialA
   44. PatientTransferForm_SITTr
   45. Baseline Infarctlike Lesion Measurement
   46. Secondary End Point Form Tia

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Data ElementVariables
Achenbach Child Behavior Checklist (CBCL)
Bayley Scale of Infant and Toddler Development
Behavior Rating Inventory of Executive Function (BRIEF) sit221_bri22
sit221_control22
sit221_gec22
sit221_gender22
sit221_inconsistency22
sit221_inhibit22
sit221_initiate22
sit221_memory22
sit221_mi22
sit221_monitor22
sit221_negativity22
sit221_organization22
sit221_plan22
sit221_shift22
California Verbal Learning Test
Children's Memory Scale
Connor's Continuous Performance Test II
Delis-Kaplan Executive Function System (D-KEFS)
NeuroQOL Cognitive Function
Peabody Picture Vocabulary Test (PPVT)
Data ElementVariables
Adaptive Behavior Assessment System-II
Adverse Childhood Experience Questionnaire (ACE-Q)
Beery Developmental Test of Visual-Motor Integration
Benton Tactile Form Perception Test
Mini Mental Status Examination (MMSE)
Oral Verbal Fluency Test
PROMIS Cognitive Function
Purdue Pegboard (SPA version)
Test of Everyday Attention (TEA)
Vineland Adaptive Behavior Summary
Wechsler Intelligence Scales sit210_block21
sit210_gender21
sit210_matrix21
sit210_similarities21
sit210_vocab21
Wechsler Memory Scale
Wisconsin Card Sorting Test
Woodcock-Johnson Revised, Tests of Achievement
Woodcock-Johnson, Revised, Tests of Cognitive Ability
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