NCT00971698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1.5 years

First QC Date

September 3, 2009

Last Update Submit

August 25, 2011

Conditions

Sickle Cell AnemiaThalassemia

Keywords

SplenectomyThrombocytosisInfectionsSpleenSickle Cell Thalassemia

Outcome Measures

Primary Outcomes (1)

  • Clinical events and abnormal laboratory results

    One year

Study Arms (2)

Sickle Cell Patients

Patients with homozygous Sickle Cell Anemia

Sickle Cell Thalassemia

Patients with Sickle Cell Thalassemia

Eligibility Criteria

Age1 Year - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All the patients followed up at the Pediatric Hematology Unit

You may not qualify if:

  • Patients lost from follow up of with insufficient data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Anemia, Sickle CellThalassemiaThrombocytosisInfections

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBlood Platelet DisordersMyeloproliferative DisordersBone Marrow Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Hematology Unit and Pediatric Dpt B

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

IL(1)