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

A Study on the Alteration of Macrophage Function in the Spleen Tissue From Patients With Primary Immune Thrombocytopenia (ITP): a Multicenter, Perspective, Clinical Trial

Sponsors

Lead Sponsor: Shandong University

Source Shandong University
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).

Overall Status Withdrawn
Start Date November 2012
Primary Completion Date September 2013
Study Type Observational
Primary Outcome
Measure Time Frame
Evaluation of platelet response (Complete Response) The time frame is up to 3 months per subject
Evaluation of platelet response (R) The time frame is up to 3 months per subject
Evaluation of platelet response (No Response) The time frame is up to 3 months per subject
Secondary Outcome
Measure Time Frame
Macrophage Function two weeks
Condition
Eligibility

Sampling Method: Probability Sample

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.

Gender: All

Minimum Age: 15 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jun Peng, dr. Principal Investigator Qilu Hospital, Shandong University
Location
Facility: Qilu Hospital, Shandong University
Location Countries

China

Verification Date

April 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: ITP patients accepted splenectomy

Label: Trauma with spleen rupture underwent splenectomy

Acronym ITP
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov