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The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00971698
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : August 26, 2011
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Study Description
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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
Sickle Cell Anemia 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.

Study Design
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Study Type : Observational
Estimated 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 : February 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Thalassemia

Groups and Cohorts
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Group/Cohort
Sickle Cell Patients
Patients with homozygous Sickle Cell Anemia
Sickle Cell Thalassemia
Patients with Sickle Cell Thalassemia


Outcome Measures
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Primary Outcome Measures :
  1. Clinical events and abnormal laboratory results [ Time Frame: One year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971698


Locations
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Israel
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
More Information
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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: September 4, 2009    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011
Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Splenectomy
Thrombocytosis
Infections
Spleen
Sickle Cell Thalassemia
Additional relevant MeSH terms:
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Anemia
Thalassemia
Anemia, Sickle Cell
Hematologic Diseases
 Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn