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

NCT ID: NCT01869049

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30

Brief Summary

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).

Conditions

Immune Thrombocytopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ITP patients accepted splenectomy

No interventions assigned to this group

Trauma with spleen rupture underwent splenectomy

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Peng, dr.

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

81070396

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ITP-Spleen

Identifier Type: -

Identifier Source: org_study_id