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

NCT00005570 | Completed

• 2 other identifiers: 00012000-H-0120
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Purpura, Thrombocytopenic, Idiopathic; Immune Thrombocytopenic Purpura

Keywords

Bleeding; Cytokines; Immune Response; Pharmacogenomic; Serum Antibodies; ITP; Immune Thrombocytopenia Purpura

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 6210960 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Hemorrhage

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 22, 2000
• First Posted: December 10, 2002
• Study Start: April 1, 2000
• Study Completion: July 1, 2000
• Last Updated: March 4, 2008

Record last verified: 2000-04

Locations

US (1)