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

NCT01869049 | Withdrawn DMC

• 2 other identifiers: ITP-Spleen81070396
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Immune Thrombocytopenia; macrophage; spleen tissue

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Macrophage Function

  two weeks

Study Arms (2)

ITP patients accepted splenectomy

Trauma with spleen rupture underwent splenectomy

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese Adult with primary immune thrombocytopenia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The biospecimens were retained for PCR, western blotting and FACS analysis.

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

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; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Jun Peng, dr.

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: June 5, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Last Updated: April 20, 2016

Record last verified: 2013-04

Locations

CN (1)