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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

September 3, 2009
August 25, 2011
February 2009
August 2010   (final data collection date for primary outcome measure)
Clinical events and abnormal laboratory results [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00971698 on ClinicalTrials.gov Archive Site
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The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia
The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia. Clinical Presentation and Follow up. Splenectomy, Indications and Complications.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

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

  • Sickle Cell Anemia
  • Thalassemia
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  • Sickle Cell Patients
    Patients with homozygous Sickle Cell Anemia
  • Sickle Cell Thalassemia
    Patients with Sickle Cell Thalassemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All the patients followed up at the Pediatric Hematology Unit

Exclusion Criteria:

  • Patients lost from follow up of with insufficient data
Both
1 Year to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00971698
0135-08-EMC
No
Dr Koren Ariel, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
Not Provided
HaEmek Medical Center, Israel
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP