STOP II
Optimizing Primary Stroke Prevention in Sickle Cell Anemia
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Status:
Trial halted in November 2004 after early results indicated an increased stroke risk among the patients in whom transfusions were discontinued.
Purpose:
To determine whether regular transfusions can be discontinued without increasing the risk of stroke in children with sickle-cell anemia who have been chronically transfused for a period of 30 months.
Interventions:
Transfusion
Blood exchange for stroke prophylaxis in sickle cell anemia
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Year Started:
2000
Year Presented:
2004
Design:
Randomized, multi-center clinical trial. A follow-up to the STOP trial.
Inclusion Criteria
Patients with sickle-cell anemia or S-beta thalassemia whose Doppler studies normalized after 30 or more months of transfusion were eligible for this study.
Patient Involvement:
Patients who have been receiving regular transfusions for 30 months will be randomized to continue or to cease transfusion treatment. Patients will be examined quarterly for a period of 18 months. Those who revert to a high risk of stroke will be reassigned to the alternate group.
Primary Outcome:
Incidence of stroke or reversion to high risk of stroke, defined as transcranial Doppler (TCD) measured flow rate >= 200 cm/s.
Results:
The trial had enrolled 79 patients when it was stopped two years early. Of the 41 patients in whom transfusions were discontinued, 14 (34%) reverted to a high risk of stroke and 2 patients had suffered a stroke. There were no events nor increases in stroke risk among the patients who continued transfusions.
Source of Information:
N Engl J Med 2005;353:2769-78.
Clinical Trials.gov.
National Heart, Lung, and Blood Institute.
Presented at the American Society of Hematology Annual Meeting (December 2004).
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This information last updated on: 9/18/2008
Reviewed on: 09/18/2008.
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