Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006182
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-08-21
Brief Title:
Stroke Prevention in Sickle Cell Anemia STOP 2
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine how long blood transfusions are needed for primary stroke prevention Also to determine the duration of risk associated with abnormal transcranial Doppler ultrasound TCD and to determine the specificity of the stroke risk model developed in STOP 1 in patients with abnormal TCD measurements
Detailed Description:
BACKGROUND
Without intervention 11 percent of children with sickle cell anemia will sustain a stroke before the age of 20 The STOP 2 follows on the recently completed NHLBI trial Stroke Prevention Trial in Sickle Cell Anemia STOP 1 which found that patients at high risk for stroke could be identified using transcranial Doppler TCD ultrasound and that the incidence of stroke could be reduced by 90 percent in those children by periodic blood transfusion for at least 36 months However chronic intermittent blood transfusions are cumbersome expensive and associated with morbidity from iron overload Thus this study to determine if transfusion can be safely halted after 30 months of treatment is critically important to the continued clinical care of patients with sickle cell disease at risk for stroke
DESIGN NARRATIVE
In this multicenter randomized clinical trial 100 children will be randomized to continue to receive periodic transfusion therapy and 50 to discontinue receiving periodic transfusion therapy The primary endpoint will be the reversion of the transcranial Doppler velocity levels to greater than 200 cmsecond indicating return of increased risk for overt stroke Recruitment will be in two phases Phase I will include those patients who began transfusions before April 1 1999 These will come mainly from the STOP 1 cohort Those who begin transfusions after April 1 1999 but before April 1 2001 will be eligible for Phase II of recruitment All patients will receive quarterly TCD examinations Patients who revert to high risk will be offered return to transfusion The overall design includes a three month start-up the two phases of recruitment established STOP patients and new patients for a total of 36 months 18 months of observations after recruitment ends and then 3 months of wrap-up
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Without intervention 11 percent of children with sickle cell anemia will sustain a stroke before the age of 20 The STOP 2 follows on the recently completed NHLBI trial Stroke Prevention Trial in Sickle Cell Anemia STOP 1 which found that patients at high risk for stroke could be identified using transcranial Doppler TCD ultrasound and that the incidence of stroke could be reduced by 90 percent in those children by periodic blood transfusion for at least 36 months However chronic intermittent blood transfusions are cumbersome expensive and associated with morbidity from iron overload Thus this study to determine if transfusion can be safely halted after 30 months of treatment is critically important to the continued clinical care of patients with sickle cell disease at risk for stroke
DESIGN NARRATIVE
In this multicenter randomized clinical trial 100 children will be randomized to continue to receive periodic transfusion therapy and 50 to discontinue receiving periodic transfusion therapy The primary endpoint will be the reversion of the transcranial Doppler velocity levels to greater than 200 cmsecond indicating return of increased risk for overt stroke Recruitment will be in two phases Phase I will include those patients who began transfusions before April 1 1999 These will come mainly from the STOP 1 cohort Those who begin transfusions after April 1 1999 but before April 1 2001 will be eligible for Phase II of recruitment All patients will receive quarterly TCD examinations Patients who revert to high risk will be offered return to transfusion The overall design includes a three month start-up the two phases of recruitment established STOP patients and new patients for a total of 36 months 18 months of observations after recruitment ends and then 3 months of wrap-up
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL052016 | NIH | None | httpsreporternihgovquickSearchU01HL052016 |