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The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00971698
First received: September 3, 2009
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Sickle Cell Anemia
Thalassemia

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Clinical events and abnormal laboratory results [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sickle Cell Patients
Patients with homozygous Sickle Cell Anemia
Sickle Cell Thalassemia
Patients with Sickle Cell Thalassemia

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.

  Eligibility

Ages Eligible for Study:   1 Year to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Two groups of patients: 25 patients with homozygous Sickle Cell Anemia and 25 patients with Sickle Cell Thalassemia

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971698

Locations
Israel
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00971698     History of Changes
Other Study ID Numbers: 0135-08-EMC
Study First Received: September 3, 2009
Last Updated: August 25, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Splenectomy
Thrombocytosis
Infections
Spleen
Sickle Cell Thalassemia

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Thalassemia
Hematologic Diseases
 Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on June 18, 2013