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Immune Thrombocytopenia | The Alteration of Macrophage Function in the Spleen Tissues From Patients With Primary Immune Thrombocytopenia

Immune Thrombocytopenia research study

What is the primary objective of this study?

This project was undertaken by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to report the alteration on the macrophage function in the spleen tissue of primary immune thrombocytopenia (ITP).

Who is eligible to participate?

Inclusion Criteria: - adult ITP patients whose platelet counts remain less than 10 x 10^9/L - patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment - patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months - require continuous glucocorticoid therapy to maintain safe platelet counts - Willing and able to sign written informed consent. Exclusion Criteria: - Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. - Current HIV infection or hepatitis B virus or hepatitis C virus infections. - Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) - Female patients who are pregnant. - Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. - Patients who are deemed unsuitable for the study by the investigator.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Immune Thrombocytopenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ITP patients accepted splenectomy

Trauma with spleen rupture underwent splenectomy

Study Status

Withdrawn

Start Date: November 2012

Completed Date:

Phase:

Type: Observational

Design:

Primary Outcome: Evaluation of platelet response (Complete Response)

Secondary Outcome: Macrophage Function

Study sponsors, principal investigator, and references

Principal Investigator: Jun Peng, dr.

Lead Sponsor: Shandong University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01869049

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