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Stroke With Transfusions Changing to Hydroxyurea

Primary Purpose

Hemochromatosis, Cerebrovascular Accident, Anemia, Sickle Cell

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Red Cell Transfusions
Iron Chelation
Hydroxyurea
Phlebotomy
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemochromatosis focused on measuring Blood Diseases

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pediatric subjects with severe forms of sickle cell anemia (HbSS, HbSβ0 thalassemia, HbSOArab) Age range of 5.0-18.9 years, inclusive, at the time of study entry Initial (primary) completed overt clinical stroke after the age of one year (12 months) with documented infarction on brain computed tomography (CT) or magnetic resonance imaging (MRI) At least 18 months of chronic monthly erythrocyte transfusions since primary stroke Transfusional iron overload, defined as a previously documented liver iron concentration (LIC) greater than or equal to 5.0 mg Fe per gram of dry weight liver or serum ferritin greater than or equal to 500 ng/mL on two independent measurements Adequate monthly erythrocyte transfusions with average HbS less than or equal to 45% (the upper limit of the established academic community standard) in the 6 months prior to study entry Parent or guardian willing and able to provide informed consent with verbal or written assent from the child (less than 18 years of age) or subject willing and able to provide informed consent (older than 18 years of age) Ability to comply with study-related treatments, evaluations, and follow-up Exclusion Criteria: Inability to receive or tolerate chronic red blood cell (RBC) transfusion therapy, due to any of the following: Multiple RBC alloantibodies making cross-matching difficult or impossible RBC autoantibodies making cross-matching difficult or impossible Religious objection to transfusions that preclude their chronic use Non-compliance with transfusions in the 6 months prior to study entry (temporary exclusion) Inability to take or tolerate daily oral hydroxyurea, due to any of the following: Known allergy to hydroxyurea therapy HIV infection Cancer Pregnant or breastfeeding Previous stem cell transplant or other myelosuppressive therapy Clinical and laboratory evidence of hypersplenism, due to any of the following: Palpable splenomegaly greater than 5 cm below the left costal margin and Transfusion requirement greater than 250 mL/kg in the 12 months prior to study entry Abnormal laboratory values at initial evaluation (temporary exclusion): Pre-transfusion hemoglobin concentration less than 7.0 gm/dL White blood cell (WBC) count less than 3.0 x 109/L Absolute neutrophil count (ANC) less than 1.5 x 109/L Platelet count less than 100 x 109/L Serum creatinine more than twice the upper limit for age OR greater than or equal to 1.0 mg/dL Current participation in other therapeutic clinical trials Current use of other therapeutic agents for SCA (e.g., arginine, decitabine, magnesium) Any condition or chronic illness, such as a positive tuberculin (PPD) test, which in the opinion of the study physician makes study participation ill-advised Inability or unwillingness to complete required screening studies, including blood tests, brain MRI/magnetic resonance angiography (MRA), and liver biopsy A sibling enrolled in SWiTCH

Sites / Locations

  • University of Alabama at Birmingham
  • Children's National Medical Center
  • Nemours Children's Clinic
  • University of Miami, Jackson Memorial Hospital
  • Nemours Children's Clinic
  • Children's Healthcare of Atlanta at Egleston
  • Children's Healthcare of Atlanta at Grady
  • Children's Healthcare of Atlanta at Scottish Rite
  • Children's Memorial Hospital
  • Boston Children's Hospital
  • Wayne State University, Children's Hospital of Michigan
  • University of Mississippi Medical Center
  • The Children's Mercy Hospital
  • St. Joseph's Children's Hospital
  • Montefiore Medical Center
  • State University of New York/Downstate Medical Center
  • Schneider Children's Hospital
  • Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian
  • East Carolina University
  • Cincinnati Children's Hospital
  • The Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh of UPMC
  • Medical University of South Carolina
  • St. Jude Children's Research Hospital
  • University of Texas Southwestern Medical Center at Dallas
  • Baylor College of Medicine
  • Eastern Virginia Medical School
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Hydroxyurea and phlebotomy

Transfusion and chelation

Outcomes

Primary Outcome Measures

Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period
Secondary stroke is the first component of the composite primary endpoint and considers the number of participants with recurrent secondary stroke events during 30 months of treatment. Stroke was defined as any clinical event with brain injury due to vascular disease. All neurological events underwent formal stroke adjudication.
Liver Iron Content (LIC) Change-from-baseline
LIC change-from-baseline is the second component of the composite primary endpoint. LIC was measured by quantitative liver biopsy at baseline and at 30 months or exit from the study.LIC values were transformed into Log10 values prior to computing the change from baseline.

Secondary Outcome Measures

Pediatric Quality of Life (PedsQL) - Parent Report (Change From Baseline)
The PedsQL(TM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.
Pediatric Quality of Life (PedsQL) - Child Report (Change From Baseline)
The PedsQLTM Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.
Barthel Index (Change From Baseline)
The Barthel Index is a measure of activities of daily living (ADL) and assesses the degree of disability in a particular participant. The index records indicators of independence in terms of the disability caused by impairments, such as those that may be sequelae of stroke. The index was used as a record of what the participant did, not as a record of what the participant could do. Barthel scores range from 0 to 100, with higher scores indicating greater independence in daily living activities (caring for oneself).
Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)-Excluding Verbal
This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Scaled scores range from 0-100. Higher scores mean better abilities/achievements.
Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)- Verbal Ability
This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Higher scores mean better abilities/achievements. Scaled scores range from 0-100.
Growth and Development - Height (Change From Baseline to Endpoint)
Growth and Development - Weight (Change From Baseline to Endpoint)

Full Information

First Posted
July 20, 2005
Last Updated
January 14, 2013
Sponsor
St. Jude Children's Research Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00122980
Brief Title
Stroke With Transfusions Changing to Hydroxyurea
Official Title
Stroke With Transfusions Changing to Hydroxyurea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
The study has been stopped due to safety and futility concerns.
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
BACKGROUND: Stroke occurs in 10% of children with SCA and has a very high risk of recurrence without therapy. Affected children receive chronic erythrocyte transfusions to prevent a secondary stroke, which are effective but have limited long-term utility due to transmission of infectious agents, erythrocyte alloantibody and autoantibody formation, and iron overload. Transfusion acquired iron overload can cause chronic organ damage with hepatic fibrosis and cirrhosis, poor growth and development, cardiac arrhythmias, and early sudden death in young patients with SCA and stroke. An alternative to transfusions for secondary stroke prevention that also addresses the issue of transfusion acquired iron overload is clearly needed. Hydroxyurea can prevent acute vaso-occlusive events in SCA, but its utility for cerebrovascular disease and for the prevention of secondary stroke in SCA is not proven. Pilot data indicate hydroxyurea can prevent stroke recurrence in children with SCA; after transfusions are discontinued, serial phlebotomy reduces iron burden. DESIGN NARRATIVE: This is a Phase III randomized clinical trial for children with SCA. The hypothesis is that hydroxyurea and phlebotomy can maintain an acceptable stroke recurrence rate and significantly reduce the hepatic iron burden. The primary aim 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. Additional aims include comparisons of growth and development, frequency of non-stroke neurological and other sickle-related events, and quality of life. The use of hydroxyurea for secondary stroke prevention, coupled with removal of excess iron by phlebotomy, would represent a significant improvement in the management of individuals with SCA and stroke. If hydroxyurea is effective for the prevention of secondary stroke, it may also be beneficial for other children with SCA and cerebrovascular disease, including those at risk for primary stroke. The trial includes approximately 130 children (5.0-18.9 years of age with 65 subjects per treatment arm) with SCA who have had symptomatic cerebral infarctions and have been treated with red cell transfusions for at least 18 months. After completing baseline screening studies, half the participants will be switched to a therapeutic program of hydroxyurea and phlebotomy. Half of the participants will remain on transfusion and chelation. The composite primary endpoint in this study is to compare two modalities of treatment for the prevention of secondary stroke and management of iron overload. The impetus for this trial is the fact that long-term transfusion and chelation therapy in children is difficult, is frequently unsuccessful, and is often complicated by severe symptomatic iron overload, particularly of the heart, lungs, and liver.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemochromatosis, Cerebrovascular Accident, Anemia, Sickle Cell, Hematologic Diseases
Keywords
Blood Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Hydroxyurea and phlebotomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Transfusion and chelation
Intervention Type
Procedure
Intervention Name(s)
Red Cell Transfusions
Intervention Description
Red Blood Cell Transfusions
Intervention Type
Procedure
Intervention Name(s)
Iron Chelation
Intervention Description
Iron Chelation Therapy
Intervention Type
Drug
Intervention Name(s)
Hydroxyurea
Intervention Description
Hydroxyurea
Intervention Type
Procedure
Intervention Name(s)
Phlebotomy
Intervention Description
Phlebotomy
Primary Outcome Measure Information:
Title
Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period
Description
Secondary stroke is the first component of the composite primary endpoint and considers the number of participants with recurrent secondary stroke events during 30 months of treatment. Stroke was defined as any clinical event with brain injury due to vascular disease. All neurological events underwent formal stroke adjudication.
Time Frame
Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)
Title
Liver Iron Content (LIC) Change-from-baseline
Description
LIC change-from-baseline is the second component of the composite primary endpoint. LIC was measured by quantitative liver biopsy at baseline and at 30 months or exit from the study.LIC values were transformed into Log10 values prior to computing the change from baseline.
Time Frame
Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life (PedsQL) - Parent Report (Change From Baseline)
Description
The PedsQL(TM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.
Time Frame
Baseline, mid-point (week 64), and study exit after up to 30-month treatment period (due to study termination)
Title
Pediatric Quality of Life (PedsQL) - Child Report (Change From Baseline)
Description
The PedsQLTM Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. It has a Likert 5-points scale (never to almost always) which were transformed to a 0 to 100 scale based on the PedsQL scoring algorithms, higher scores indicating better quality of life characteristics.
Time Frame
Baseline, midpoint (week 64), and study exit (up to 30 months of treatment)
Title
Barthel Index (Change From Baseline)
Description
The Barthel Index is a measure of activities of daily living (ADL) and assesses the degree of disability in a particular participant. The index records indicators of independence in terms of the disability caused by impairments, such as those that may be sequelae of stroke. The index was used as a record of what the participant did, not as a record of what the participant could do. Barthel scores range from 0 to 100, with higher scores indicating greater independence in daily living activities (caring for oneself).
Time Frame
Baseline and study exit after up to 30-month treatment period (due to study termination)
Title
Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)-Excluding Verbal
Description
This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Scaled scores range from 0-100. Higher scores mean better abilities/achievements.
Time Frame
Baseline and study exit after up to 30-month treatment period (due to study termination)
Title
Woodcock-Johnson Test of Cognitive Abilities (WJ-C) and Achievement (WJ-III) (Change From Baseline)- Verbal Ability
Description
This test is designed to assess both broad and narrow cognitive abilities in children age 4 years and above as well as to measure major aspects of academic achievement in persons aged 2-90 years. Higher scores mean better abilities/achievements. Scaled scores range from 0-100.
Time Frame
Baseline and study exit after up to 30-month treatment period (due to study termination)
Title
Growth and Development - Height (Change From Baseline to Endpoint)
Time Frame
Baseline to end of study participation (up to 136 weeks)
Title
Growth and Development - Weight (Change From Baseline to Endpoint)
Time Frame
baseline to end of study participation (up to 136 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric subjects with severe forms of sickle cell anemia (HbSS, HbSβ0 thalassemia, HbSOArab) Age range of 5.0-18.9 years, inclusive, at the time of study entry Initial (primary) completed overt clinical stroke after the age of one year (12 months) with documented infarction on brain computed tomography (CT) or magnetic resonance imaging (MRI) At least 18 months of chronic monthly erythrocyte transfusions since primary stroke Transfusional iron overload, defined as a previously documented liver iron concentration (LIC) greater than or equal to 5.0 mg Fe per gram of dry weight liver or serum ferritin greater than or equal to 500 ng/mL on two independent measurements Adequate monthly erythrocyte transfusions with average HbS less than or equal to 45% (the upper limit of the established academic community standard) in the 6 months prior to study entry Parent or guardian willing and able to provide informed consent with verbal or written assent from the child (less than 18 years of age) or subject willing and able to provide informed consent (older than 18 years of age) Ability to comply with study-related treatments, evaluations, and follow-up Exclusion Criteria: Inability to receive or tolerate chronic red blood cell (RBC) transfusion therapy, due to any of the following: Multiple RBC alloantibodies making cross-matching difficult or impossible RBC autoantibodies making cross-matching difficult or impossible Religious objection to transfusions that preclude their chronic use Non-compliance with transfusions in the 6 months prior to study entry (temporary exclusion) Inability to take or tolerate daily oral hydroxyurea, due to any of the following: Known allergy to hydroxyurea therapy HIV infection Cancer Pregnant or breastfeeding Previous stem cell transplant or other myelosuppressive therapy Clinical and laboratory evidence of hypersplenism, due to any of the following: Palpable splenomegaly greater than 5 cm below the left costal margin and Transfusion requirement greater than 250 mL/kg in the 12 months prior to study entry Abnormal laboratory values at initial evaluation (temporary exclusion): Pre-transfusion hemoglobin concentration less than 7.0 gm/dL White blood cell (WBC) count less than 3.0 x 109/L Absolute neutrophil count (ANC) less than 1.5 x 109/L Platelet count less than 100 x 109/L Serum creatinine more than twice the upper limit for age OR greater than or equal to 1.0 mg/dL Current participation in other therapeutic clinical trials Current use of other therapeutic agents for SCA (e.g., arginine, decitabine, magnesium) Any condition or chronic illness, such as a positive tuberculin (PPD) test, which in the opinion of the study physician makes study participation ill-advised Inability or unwillingness to complete required screening studies, including blood tests, brain MRI/magnetic resonance angiography (MRA), and liver biopsy A sibling enrolled in SWiTCH
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell E. Ware, MD, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald W. Helms, PhD
Organizational Affiliation
Rho Incorporated
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami, Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nemours Children's Clinic
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Children's Healthcare of Atlanta at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Healthcare of Atlanta at Grady
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Healthcare of Atlanta at Scottish Rite
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Wayne State University, Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
St. Joseph's Children's Hospital
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
State University of New York/Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24914136
Citation
Helton KJ, Adams RJ, Kesler KL, Lockhart A, Aygun B, Driscoll C, Heeney MM, Jackson SM, Krishnamurti L, Miller ST, Sarnaik SA, Schultz WH, Ware RE; SWiTCH Investigators. Magnetic resonance imaging/angiography and transcranial Doppler velocities in sickle cell anemia: results from the SWiTCH trial. Blood. 2014 Aug 7;124(6):891-8. doi: 10.1182/blood-2013-12-545186. Epub 2014 Jun 9.
Results Reference
derived
PubMed Identifier
23861242
Citation
Alvarez O, Yovetich NA, Scott JP, Owen W, Miller ST, Schultz W, Lockhart A, Aygun B, Flanagan J, Bonner M, Mueller BU, Ware RE; Investigators of the Stroke With Transfusions Changing to Hydroxyurea Clinical Trial (SWiTCH). Pain and other non-neurological adverse events in children with sickle cell anemia and previous stroke who received hydroxyurea and phlebotomy or chronic transfusions and chelation: results from the SWiTCH clinical trial. Am J Hematol. 2013 Nov;88(11):932-8. doi: 10.1002/ajh.23547. Epub 2013 Aug 30.
Results Reference
derived
PubMed Identifier
22318199
Citation
Ware RE, Helms RW; SWiTCH Investigators. Stroke With Transfusions Changing to Hydroxyurea (SWiTCH). Blood. 2012 Apr 26;119(17):3925-32. doi: 10.1182/blood-2011-11-392340. Epub 2012 Feb 7.
Results Reference
derived
PubMed Identifier
21826782
Citation
Ware RE, Schultz WH, Yovetich N, Mortier NA, Alvarez O, Hilliard L, Iyer RV, Miller ST, Rogers ZR, Scott JP, Waclawiw M, Helms RW. Stroke With Transfusions Changing to Hydroxyurea (SWiTCH): a phase III randomized clinical trial for treatment of children with sickle cell anemia, stroke, and iron overload. Pediatr Blood Cancer. 2011 Dec 1;57(6):1011-7. doi: 10.1002/pbc.23145. Epub 2011 Aug 8.
Results Reference
derived

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Stroke With Transfusions Changing to Hydroxyurea

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