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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Shandong University
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01869049
First received: April 3, 2013
Last updated: May 30, 2013
Last verified: April 2013
  Purpose

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).


Condition
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

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
ITP patients accepted splenectomy
Trauma with spleen rupture underwent splenectomy

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chinese Adult with primary immune thrombocytopenia

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869049

Contacts
Contact: Jun Peng, dr. +8613553157577 junpeng88@gmail.com

Locations
China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Jun Peng, dr.    +8613553157577    junpeng88@gmail.com   
Principal Investigator: Jun Peng, dr.         
Sponsors and Collaborators
Shandong University
Investigators
Principal Investigator: Jun Peng, dr. Qilu Hospital, Shandong University
  More Information

No publications provided

Responsible Party: Ming Hou, professor, Shandong University
ClinicalTrials.gov Identifier: NCT01869049     History of Changes
Other Study ID Numbers: ITP-Spleen, 81070396
Study First Received: April 3, 2013
Last Updated: May 30, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
Immune Thrombocytopenia
macrophage
spleen tissue

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014