NCT00402480

Brief Summary

The purpose of this study is to assess prospectively the efficacy of hydroxyurea therapy in the setting of cerebrovascular disease, manifest as conditional or abnormal transcranial doppler ultrasonography (TCD) flow velocities, in children with sickle cell anemia (SCA). TCD is used to measure flow velocity in intracranial arteries as a marker of increased stroke risk in children with SCA. The primary objective of this protocol is to determine whether hydroxyurea reduces elevated TCD velocity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started Apr 2003

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
Last Updated

June 19, 2013

Status Verified

November 1, 2006

First QC Date

November 21, 2006

Last Update Submit

June 17, 2013

Conditions

Stroke

Keywords

Sickle Cell Anemia with Elevated TCD flow velocity

Outcome Measures

Primary Outcomes (1)

  • Change in TCD flow velocity

Secondary Outcomes (1)

  • Stroke

Interventions

HydroxyureaDRUG

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with Sickle Cell Anemia
  • Aged 3 to 18 years
  • Confirmed TCD velocity greater than or equal to 140cm/sec
  • Negative serum pregnancy test for subjects of childbearing potential
  • Decline transfusions (for subjects with TCD velocity greater than or equal to 200 cm/sec)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Officials

  • Sherri Zimmerman, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 22, 2006

Study Start

April 1, 2003

Study Completion

March 1, 2006

Last Updated

June 19, 2013

Record last verified: 2006-11

Locations

US(1)