Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000592
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
1999-10-27
Brief Title:
Stroke Prevention in Sickle Cell Anemia STOP 1
Sponsor:
Augusta University
Organization:
Augusta University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-11
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 reduce episodes of first time stroke by 75 percent in children with sickle cell anemia by the administration of prophylactic transfusion therapy
Detailed Description:
BACKGROUND
Stroke occurring in about 10 percent of pediatric patients with sickle cell disease is one of the most devastating complications with a high recurrence rate after the first episode Several non-randomized studies have shown reduction in stroke recurrence when periodic blood transfusions are administered to maintain hemoglobin S under 30 percent Periodic blood transfusions are associated with significant risks of iron overload and other complications and must be accompanied by parenteral iron chelation therapy However this has become a standard of care for prevention of recurrent stroke in SS children Thus a randomized trial of blood transfusion for secondary prevention would not be feasible because it would be considered unethical Based on various studies the recurrence rate is reduced from 46 to 67 percent to approximately 7 percent on transfusion therapy Because most stroke patients are left with some neurological deficit and face a lifetime of disability primary prevention would have a significant impact on the management of patients However because of complications of blood transfusions the hypothesis should be proven by a randomized clinical trial
A primary prevention trial had not been possible because an acceptable means of detecting those children at risk of stroke was not available The advent of TCD to identify arterial abnormalities for the prediction of stroke has provided a means of detection TCD abnormalities have a high specificity 100 percent and high sensitivity 90 percent for detecting angiographically proven narrowing of arterial diameter Thus TCD examination of the basal cerebral arteries is predictive of who will develop a stroke
DESIGN NARRATIVE
Randomized Phase III multicenter Approximately 3000 children from 12 clinics were screened with transcranial Doppler TCD A total of 130 were randomized to receive either standard supportive care or periodic blood transfusions if they were found to be at high risk of stroke on the basis of elevated cerebral blood flow as measured by TCD screening tests Primary endpoints included clinically evident symptoms of cerebral infarction with consistent findings on magnetic resonance imaging MRI andor symptomatic intracranial hemorrhage Secondary endpoints included asymptomatic brain lesions detected by MRI in brain areas not involved in primary endpoints Hematologic characteristics of the high risk group were analyzed and serum and DNA samples frozen for future analysis Recruitment ended in October 1997 with the accrual of 130 subjects The clinical phase ended in 1999
Stroke occurring in about 10 percent of pediatric patients with sickle cell disease is one of the most devastating complications with a high recurrence rate after the first episode Several non-randomized studies have shown reduction in stroke recurrence when periodic blood transfusions are administered to maintain hemoglobin S under 30 percent Periodic blood transfusions are associated with significant risks of iron overload and other complications and must be accompanied by parenteral iron chelation therapy However this has become a standard of care for prevention of recurrent stroke in SS children Thus a randomized trial of blood transfusion for secondary prevention would not be feasible because it would be considered unethical Based on various studies the recurrence rate is reduced from 46 to 67 percent to approximately 7 percent on transfusion therapy Because most stroke patients are left with some neurological deficit and face a lifetime of disability primary prevention would have a significant impact on the management of patients However because of complications of blood transfusions the hypothesis should be proven by a randomized clinical trial
A primary prevention trial had not been possible because an acceptable means of detecting those children at risk of stroke was not available The advent of TCD to identify arterial abnormalities for the prediction of stroke has provided a means of detection TCD abnormalities have a high specificity 100 percent and high sensitivity 90 percent for detecting angiographically proven narrowing of arterial diameter Thus TCD examination of the basal cerebral arteries is predictive of who will develop a stroke
DESIGN NARRATIVE
Randomized Phase III multicenter Approximately 3000 children from 12 clinics were screened with transcranial Doppler TCD A total of 130 were randomized to receive either standard supportive care or periodic blood transfusions if they were found to be at high risk of stroke on the basis of elevated cerebral blood flow as measured by TCD screening tests Primary endpoints included clinically evident symptoms of cerebral infarction with consistent findings on magnetic resonance imaging MRI andor symptomatic intracranial hemorrhage Secondary endpoints included asymptomatic brain lesions detected by MRI in brain areas not involved in primary endpoints Hematologic characteristics of the high risk group were analyzed and serum and DNA samples frozen for future analysis Recruitment ended in October 1997 with the accrual of 130 subjects The clinical phase ended in 1999
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 |
|---|---|---|---|
| U01HL052193 | NIH | None | httpsreporternihgovquickSearchU01HL052193 |