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An Epidemiological Study of Subjects With Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers

Primary Purpose

Purpura, Thrombocytopenic, Idiopathic, Immune Thrombocytopenic Purpura

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Purpura, Thrombocytopenic, Idiopathic focused on measuring Bleeding, Cytokines, Immune Response, Pharmacogenomic, Serum Antibodies, ITP, Immune Thrombocytopenia Purpura

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Diagnosis of ITP, based on the history, physical examination, complete blood count, and examination of the peripheral smear, which should exclude other causes of thrombocytopenia. These criteria for ITP are based on the American Society of Hematology practice guideline for ITP. Subjects 5 years of age or older. Before the study specific procedure, the subject or legally acceptable representative must give written informed consent(s) for participation in the study. No subjects with documented history of Human Immunodeficiency Virus (HIV) or Hepatitis. No subjects with known underlying causes of thrombocytopenia such as lupus erythematosus, autoimmune thyroid disorders, drug-induced thrombocytopenia, bone marrow disorders, and liver disease. No psychiatric or addictive disorders that compromise the subject's ability to give truly informed consent for participation in the study.

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 22, 2000
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005570
Brief Title
An Epidemiological Study of Subjects With Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers
Official Title
An Epidemiological Study of Subjects With Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers
Study Type
Observational

2. Study Status

Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief Summary
This study involves the collection of blood samples from patients with immune thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood levels of a hormone called thrombopoietin that controls platelet production by the bone marrow, and blood levels of antibodies against thrombopoietin that could interfere with the action of this hormone. Blood samples will also be stored if separately agreed to by the patient for analysis of genes that might affect platelet production. At a single outpatient clinic visit, patients will have a medical history taken, and blood samples drawn for testing. Results from this study may help further understand the control of platelet production in patients with ITP, and suggest new therapeutic approaches.
Detailed Description
This study involves the collection of blood samples from patients with immune thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood levels of a hormone called thrombopoietin that controls platelet production by the bone marrow, and blood levels of antibodies against thrombopoietin that could interfere with the action of this hormone. Blood samples will also be stored if separately agreed to by the patient for analysis of genes that might affect platelet production. At a single outpatient clinic visit, patients will have a medical history taken, and blood samples drawn for testing. Results from this study may help further understand the control of platelet production in patients with ITP, and suggest new therapeutic approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopenic, Idiopathic, Immune Thrombocytopenic Purpura
Keywords
Bleeding, Cytokines, Immune Response, Pharmacogenomic, Serum Antibodies, ITP, Immune Thrombocytopenia Purpura

7. Study Design

Enrollment
200 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of ITP, based on the history, physical examination, complete blood count, and examination of the peripheral smear, which should exclude other causes of thrombocytopenia. These criteria for ITP are based on the American Society of Hematology practice guideline for ITP. Subjects 5 years of age or older. Before the study specific procedure, the subject or legally acceptable representative must give written informed consent(s) for participation in the study. No subjects with documented history of Human Immunodeficiency Virus (HIV) or Hepatitis. No subjects with known underlying causes of thrombocytopenia such as lupus erythematosus, autoimmune thyroid disorders, drug-induced thrombocytopenia, bone marrow disorders, and liver disease. No psychiatric or addictive disorders that compromise the subject's ability to give truly informed consent for participation in the study.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6210960
Citation
Kelton JG, Gibbons S. Autoimmune platelet destruction: idiopathic thrombocytopenic purpura. Semin Thromb Hemost. 1982 Apr;8(2):83-104. doi: 10.1055/s-2007-1005045. No abstract available.
Results Reference
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An Epidemiological Study of Subjects With Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers

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