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The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Completed
CT.gov ID
NCT00971698
Collaborator
(none)
50
Enrollment
1
Location
17.9
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The spleen in Sickle Cell Anemia and Sickle Cell Thalassemia is usually enlarged in the first years of life but the immune protection provided is considered insufficient. In homozygous Sickle cell patients the spleen usually developed recurrent infarcts and after the first decade of age become fibrotic. Acute splenic sequestration is also frequent in those patients and this is considered as an indication for splenectomy.

In comparison in Sickle cell thalassemia patients, hypersplenism is more frequent.

The purpose of this study is to compare the clinical and laboratory issues related to the spleen in two groups of Sickle cell patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Clinical and laboratory characteristics related to the spleen in SCA patients will be studied.

    Two groups of patient will be compared, a group of Sickle cell patients (Homozygous) and a second group of patients with Sickle cell beta thalassemia.

    In those patients that splenectomy was performed the incidence of infections will be recorded besides the indications for splenectomy and the incidence of thrombotic events or thrombocytosis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia. Clinical Presentation and Follow up. Splenectomy, Indications and Complications.
    Study Start Date :
    Feb 1, 2009
    Actual Primary Completion Date :
    Aug 1, 2010
    Actual Study Completion Date :
    Aug 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Sickle Cell Patients

    Patients with homozygous Sickle Cell Anemia
    Sickle Cell Thalassemia

    Patients with Sickle Cell Thalassemia

    Outcome Measures

    Primary Outcome Measures

    1. Clinical events and abnormal laboratory results [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All the patients followed up at the Pediatric Hematology Unit
    Exclusion Criteria:
    • Patients lost from follow up of with insufficient data

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center Afula Israel 18101

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT00971698
    Other Study ID Numbers:
    • 0135-08-EMC
    First Posted:
    Sep 4, 2009
    Last Update Posted:
    Aug 26, 2011
    Last Verified:
    Aug 1, 2011
    Keywords provided by Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
    Splenectomy
    Thrombocytosis
    Infections
    Spleen
    Sickle Cell Thalassemia
    Additional relevant MeSH terms:
    Anemia
    Thalassemia
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Aug 26, 2011