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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

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

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).

Detailed Summary:
Sponsor: Shandong University

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Macrophage Function [ Time Frame: two weeks ]

Measure the platelet phagocytosis ability of macrophage in vitro


Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: April 3, 2013
Date Started: November 2012
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2013