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Stroke With Transfusions Changing to Hydroxyurea

NCT00122980 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2013-01-18

Study results available
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Summary

The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).

Conditions

Interventions

PROCEDURE

Red Cell Transfusions

Red Blood Cell Transfusions

PROCEDURE

Iron Chelation

Iron Chelation Therapy

DRUG

Hydroxyurea

Hydroxyurea

PROCEDURE

Phlebotomy

Phlebotomy

Sponsors & Collaborators

Principal Investigators

  • Russell E. Ware, MD, PhD · Baylor College of Medicine

  • Ronald W. Helms, PhD · Rho Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00122980 on ClinicalTrials.gov