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

This study has been withdrawn prior to enrollment.
(No eligible patient was enrolled.)
Information provided by (Responsible Party):
Ming Hou, Shandong University Identifier:
First received: April 3, 2013
Last updated: April 18, 2016
Last verified: April 2013
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).

Immune Thrombocytopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study on the Alteration of Macrophage Function in the Spleen Tissue From Patients With Primary Immune Thrombocytopenia (ITP): a Multicenter, Perspective, Clinical Trial

Resource links provided by NLM:

Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ]
    CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia

  • Evaluation of platelet response (R) [ Time Frame: The time frame is up to 3 months per subject ]
    R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia

  • Evaluation of platelet response (No Response) [ Time Frame: The time frame is up to 3 months per subject ]
    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.

Secondary Outcome Measures:
  • Macrophage Function [ Time Frame: two weeks ]
    Measure the platelet phagocytosis ability of macrophage in vitro

Biospecimen Retention:   Samples With DNA
The biospecimens were retained for PCR, western blotting and FACS analysis.

Enrollment: 0
Study Start Date: November 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
ITP patients accepted splenectomy
Trauma with spleen rupture underwent splenectomy


Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese Adult with primary immune thrombocytopenia

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.
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Please refer to this study by its identifier: NCT01869049

China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Principal Investigator: Jun Peng, dr. Qilu Hospital, Shandong University
  More Information

Responsible Party: Ming Hou, professor, Shandong University Identifier: NCT01869049     History of Changes
Other Study ID Numbers: ITP-Spleen
81070396 ( Other Grant/Funding Number: Natural Science Foundation of China )
Study First Received: April 3, 2013
Last Updated: April 18, 2016

Keywords provided by Shandong University:
Immune Thrombocytopenia
spleen tissue

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms processed this record on May 22, 2017