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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Immune Thrombocytopenia

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chinese Adult with primary immune thrombocytopenia

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ITP patients accepted splenectomy
Trauma with spleen rupture underwent splenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of platelet response (Complete Response)	CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia	The time frame is up to 3 months per subject
Evaluation of platelet response (R)	R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia	The time frame is up to 3 months per subject
Evaluation of platelet response (No Response)	NR.No response (NR) was defined as platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.	The time frame is up to 3 months per subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macrophage Function	Measure the platelet phagocytosis ability of macrophage in vitro	two weeks

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Jun Peng, dr., Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Immune Thrombocytopenia; macrophage; spleen tissue
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: ITP-Spleen; 81070396 (Other Grant/Funding Number: Natural Science Foundation of China)