Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea

NCT ID: NCT00480974

Last Updated: 2009-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-12-31

Brief Summary

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Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

Detailed Description

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Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

A long term follow up will be recorded in a cohort of twenty SCA patients treated by Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. Also the mean hgb level and hgb F percentage will be summarized.

Conditions

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Sickle Cell Anemia Sickle Cell Thalassemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Patients with Sickle cell anemia treated by Hydroxyurea

Clinical follow up and laboratory analysis

Intervention Type OTHER

Clinical follow up and laboratory analysis

Interventions

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Clinical follow up and laboratory analysis

Clinical follow up and laboratory analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients treated by Hydroxyurea in the Pediatric Hematology Unit.
Minimum Eligible Age

5 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Pediatric Hematology Unit - HaEmek Medical Center - Afula - Israel

Principal Investigators

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Ariel Koren, MD

Role: STUDY_DIRECTOR

Pediatric Hematology Unit, Ha'Emek Medical Center

Carina Levin, MD

Role: STUDY_CHAIR

Pediatric Hematology Unit - Ha'Emek Medical Center

Miri Golan, Student

Role: PRINCIPAL_INVESTIGATOR

Pediatric Hematology Unit - HaEmek Medical Center

Luci Zalman, PhD

Role: STUDY_CHAIR

Hematology Laboratory - HaEmek Medical Center

Locations

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Pediatric Hematology Unit - HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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5321006.EMC

Identifier Type: -

Identifier Source: org_study_id

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