Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial

Phase 3

Completed

• Conditions: Sickle Cell Anemia; Stroke
• Interventions: Procedure: transfusion therapy

• Registration Number: NCT00072761
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.

Detailed Description

Silent cerebral infarct (stroke) is the most common cause of severe cognitive impairments and related neurological functions in children with sickle cell anemia. Currently there exists no systemic strategy to identify or treat children with silent strokes.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2003-11-10
• Study First Submitted QC: 2003-11-12
• Study First Posted: 2003-11-13
• Study Start: 2004-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-05-04
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Results First Posted: 2016-02-08
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transfusion Group	transfusion therapy	Participants allocated to the transfusion arm will receive blood transfusion therapy every 4-6 weeks for 36 months.

Primary Outcome Measures

Name	Time	Method
Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct	From study entry to study exit	The primary end point was the recurrence of infarct or hemorrhage as determined by neuroimaging, clinical evidence of permanent neurologic injury, or both. A new infarct had to meet the criteria for a silent cerebral infarction; an enlarged silent cerebral infarct was defined as a previously identified silent cerebral infarct that increased by at least 3 mm ...

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States