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Study Detail

Study ID 1008
Name Stroke Prevention in Sickle Cell Anemia
Contact Email biolincc@imsweb.com
Acronym STOP I and II
Period 1994-2000, 2000-2006
Design Clinical Trial
Study PI Robert Adams, Donald Brambilla
Institution Augusta University
URL https://biolincc.nhlbi.nih.gov/studies/stop_ii/
CTGovID https://clinicaltrials.gov/ct2/show/NCT00006182
Funding Agency NHLBI
Grant Number 2U01HL052016-06A1
Overview The STOP II trial evaluated whether prophylactic transfusion in patients with sickle cell disease and high risk of stroke can be safely halted after 30 months of treatment during which patients became low risk for stroke.
Focus Areas STOP I - asymptomatic brain lesions detected by MRI in brain areas not involved in primary endpoints.
Outcomes 1. STOP I- clinically evident symptoms of cerebral infarction with consistent findings on magnetic resonance imaging (MRI), and/or symptomatic intracranial hemorrhage.
2. STOP II - stroke (cerebral infarction or intracranial hemorrhage)
3. STOP II - or reversion to abnormal velocity on TCD ultrasonography, defined as two consecutive studies with abnormal velocities, three consecutive studies with an average velocity of 200 cm/second or more, or three consecutive inadequate studies plus evidence of severe stenosis via imaging.
Data Location BioLINCC, BioData Catalyst
Biospecimen Available N/A
Data Consent Data sharing via BioLINCC
Biospecimen Consent NA
Contact Consent NA
Genomic Data No
Age Range 2-20
No. Participants 150
Inclusion Criteria 1. STOP I- Pediatric patients, ages 24 months to 16 years, with sickle cell anemia or S-beta zero thalassemia.
2. STOP II - Children and young adults 2 to 20 years of age with sickle cell anemia and no history of stroke.
3. STOP II- To be eligible for randomization, participants must have been at high risk for stroke as determined by abnormal transcranial Doppler (TCD) screening results, and then received at least 30 months of transfusions for stroke prevention during which the TCD results normalized.
4. STOP II- Subjects were considered regardless of participation in the previous STOP study.
5. STOP II - All participants were required to have normal results on two consecutive TCDs performed at least two weeks apart while they were receiving prophylactic transfusions and within four months before randomization.
Exclusion Criteria 1. Patient does not have a diagnosis of HbSS or HbS/ß0 Thalassemia.
2. Patient's age is not in the range of 2 through 16 years.
3. Patient has prior history of stroke.
4. Patient has received a bone marrow transplant.
Study Documentation
  Select All 		   1. STOP II Limited Access Data Manual
   2. Codebook
   3. Exam_Schedules
Forms
  Select All 		   1. Eligibility_Questionnaire_for_TCD_Screening_Exam
   2. Eligibility Questionnaire for Patients on Transfusion For Primary Stroke Prevention for < 30 Months
   3. Pre-Randomization Eligibility Questionnaire (for patients on transfusion for > 30 months)
   4. Transcranial Doppler (TCD) Examination Form
   5. Treatment Decision by Parent-Guardian of Newly Identified Child With Two Abnormal TCDs or One Abnormal TCD With TAMM Velocity > 220 CM/SEC
   6. Signed Acknowledgement of New Information About the STOP II Study
   7. Post-Trial Treatment Decision Form
   8. Trial Randomization Form
   9. Intake History Form
   10. Physical Examination
   11. Core Laboratory Form
   12. Local Laboratory Form for Non-Randomized Patients Receiving Transfusions
   13. Neurological Consultant Report
   14. Head MRI Scan
   15. Event CT Scan
   16. Quarterly Progress Report for Randomized Patients
   17. Quarterly Progress Report for Non-Randomized Patients Receiving Transfusions
   18. Quarterly Medical Record Review
   19. Missed Follow-Up Visit for Trial Patients
   20. Reason for Overdue TCD Exam Visit for Randomized Patient
   21. MRA Scan
   22. Transfusion Form
   23. Blood Unit Form
   24. Transfusion History Log
   25. Chelation Questionnaire for STOP II Randomized Patients
   26. Transfusion History Log for Pre-STOP II Transfusions that Are Not in FOXPRO or ADEPT for STOP Randomized Patients
   27. Neurological Event Form
   28. Non-Neurological Event Form
   29. Delayed Transfusion Reaction Form
   30. Outcome of Hospitalization for Stroke, Meningitis, or Head Injury
   31. Cause of Death Form
   32. Endpoint Adjudication Decision
   33. Quasi-Adjudication Neurological Event Form
   34. Quasi-Adjudication Consensus
   35. Patient Roster

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