The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia

Sickle Cell Anemia Clinical Trial

Official title:

The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia. Clinical Presentation and Follow up. Splenectomy, Indications and Complications.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971698
• Other study ID #: 0135-08-EMC
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: August 25, 2011
• Start date: February 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2011
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 35 Years

Eligibility

Inclusion Criteria:

• All the patients followed up at the Pediatric Hematology Unit

Exclusion Criteria:

• Patients lost from follow up of with insufficient data

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Sickle Cell Anemia
• Thalassemia

Locations

Country	Name	City	State
Israel	Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical events and abnormal laboratory results		One year	No