- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244410
Lymphocyte Counts in Immune Thrombocytopenic Purpura
Initial Lymphocyte Counts Predictive Value in Immune Thrombocytopenic Purpura
- immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number (cooper N et al 2006)
- recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( cooper N et al 2006) ( Gern Sheimer T 2009 )
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Immune thrombocytopenic purpura is an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number ( Cooper N et all 2006) platelet surface membrane proteins become antigenic for unknown reasons, leading to stimulation of the immune system, auto antibodies production and platelet destruction ( Gasbarrini A et all 2000) It is associated with the production of auto antibodies directed against platelet glycoprotein complex 2b/3a and/or 1b/1x , resulting in accelerated destruction of platelets by the reticular endothelial system via the activity of Fcc receptor bearing phagocytic cells ( Provan & Newland et al 2002) Recent studies have demonstrated that the pathogenesis of ITP envolves multifactorial autoimmune mechanisms of both humoral and cellular immunity and that acute and chronic forms may represent two distinct immunopathological disorders ( Cooper N et al 2006) ( Gern Sheimer T 2009)
There are many phases of the disease:
- Newly diagnosed ITP : for all cases at diagnosis.
- persistent ITP: for patients with ITP between 3 to 12 months.
chronic ITP: for patients with ITP lasting more than one year ( blood journal 2009).
- Although lymphocytopenia is a commonly reported feature of many chronic autoimmune disorders, differential white cell counts at presentation have seldom been evaluated as predictors for development of chronic ITP ( Deel MD et al 2013) (Ahmed et al 2010)
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed cases of primary ITP , adults and children.
Exclusion Criteria:
- Cases of secondary ITP
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
immune thrombocytopenic purpura
immune thrombocytopenic purpura an acquired autoimmune disorder characterized by increased platelet destruction and decreased platelet number we used complete blood picture
|
complete blood picture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lymphocyte count in immune thrombocytopenic purpura
Time Frame: 15 minutes
|
intital lymphocyte counts predictive value in immune thrombocytopenic purpura by complete blood picture
|
15 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- LCITP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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