Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea

This study has been completed.
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00480974
First received: May 31, 2007
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Sickle Cell Anemia
Sickle Cell Thalassemia
Other: Clinical follow up and laboratory analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Estimated Enrollment: 20
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with Sickle cell anemia treated by Hydroxyurea
Other: Clinical follow up and laboratory analysis
Clinical follow up and laboratory analysis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Sickle Cell Anemia treated at the Pediatric Hematology Unit and receiving Hydroxyurea

Criteria

Inclusion Criteria:

  • All patients treated by Hydroxyurea in the Pediatric Hematology Unit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480974

Locations
Israel
Pediatric Hematology Unit - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Director: Ariel Koren, MD Pediatric Hematology Unit, Ha'Emek Medical Center
Study Chair: Carina Levin, MD Pediatric Hematology Unit - Ha'Emek Medical Center
Principal Investigator: Miri Golan, Student Pediatric Hematology Unit - HaEmek Medical Center
Study Chair: Luci Zalman, PhD Hematology Laboratory - HaEmek Medical Center
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Pediatric Hematology Unit - HaEmek Medical Center - Afula - Israel
ClinicalTrials.gov Identifier: NCT00480974     History of Changes
Other Study ID Numbers: 5321006.EMC
Study First Received: May 31, 2007
Last Updated: September 3, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Sickle cell anemia
Sickle cell thalassemia
Hydroxyurea

Additional relevant MeSH terms:
Thalassemia
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014