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Stroke prevention trial in sickle cell anemia

R J Adams¹, V C McKie, D Brambilla

¹Department of Neurology, Medical College of Georgia, Augusta 30912-3200, USA.

Controlled Clinical Trials

|March 11, 1998

Summary

Preventing first-time stroke in children with Sickle Cell Disease (Hb SS) is crucial. The Stroke Prevention Trial in Sickle Cell Anemia (STOP) investigates if blood transfusions guided by Transcranial Doppler (TCD) ultrasound can significantly reduce stroke risk.

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Area of Science:

Pediatric Neurology
Hematology
Vascular Medicine

Background:

Stroke is a significant cause of morbidity in children with Sickle Cell Disease (Hb SS).
While chronic blood transfusions reduce stroke recurrence, primary prevention of a first stroke is essential to prevent irreversible brain injury.
Transcranial Doppler (TCD) ultrasound identifies children at high risk for stroke based on blood flow velocity.

Purpose of the Study:

To evaluate the effectiveness of periodic blood transfusions in reducing the risk of first-time stroke in children with Hb SS.
To determine if reducing sickle hemoglobin levels to ≤30% via transfusion can decrease stroke incidence by at least 70% compared to standard care.
To assess the impact of transfusions on asymptomatic brain lesions detected by MRI/MRA.

Main Methods:

The multi-center Stroke Prevention Trial in Sickle Cell Anemia (STOP) randomized children with Hb SS to receive either blood transfusions or standard care.
Screening involved standardized Transcranial Doppler (TCD) ultrasound and Magnetic Resonance Imaging/Angiography (MRI/MRA) protocols.
Primary endpoints included clinically evident cerebral infarction or intracranial hemorrhage, with blinded adjudication.

Main Results:

A time-averaged mean velocity of ≥200 cm/sec on TCD is associated with a 46% risk of cerebral infarction over 39 months.
The study is powered to detect a 70% reduction in the primary endpoint with 90% power.
Standardized TCD and MRI/MRA protocols with blinded interpretation and endpoint adjudication are key trial features.

Conclusions:

This trial aims to establish whether blood transfusions are effective in the primary prevention of stroke in children with Hb SS.
Findings will inform future research into cerebrovascular disease and optimize treatment strategies for Hb SS.
The study's design addresses the critical need for primary stroke prevention in this vulnerable pediatric population.