The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 3, 2009 |
| Last Updated Date | August 25, 2011 |
| Start Date ICMJE | February 2009 |
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Clinical events and abnormal laboratory results [ Time Frame: One year ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00971698 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia |
| Official Title ICMJE | The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia. Clinical Presentation and Follow up. Splenectomy, Indications and Complications. |
| 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. |
| 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 Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | Two groups of patients: 25 patients with homozygous Sickle Cell Anemia and 25 patients with Sickle Cell Thalassemia |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 50 |
| Completion Date | August 2010 |
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 1 Year to 35 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Israel |
| Administrative Information | |
| NCT Number ICMJE | NCT00971698 |
| Other Study ID Numbers ICMJE | 0135-08-EMC |
| Has Data Monitoring Committee | No |
| Responsible Party | Dr Koren Ariel, HaEmek Medical Center, Israel |
| Study Sponsor ICMJE | HaEmek Medical Center, Israel |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | HaEmek Medical Center, Israel |
| Verification Date | August 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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