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NCT05095896 Clinical Trial

The Serum Lipid Profiles in ITP: a Retrospective Study

Immune Thrombocytopenia Clinical Trial

Official title:
The Serum Lipid Profiles in Immune Thrombocytopenia: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05095896
Other study ID # lipid in ITP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 1, 2020

Study information
Verified date October 2021
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The project was retrospectively undertaking by Qilu Hospital of Shandong University in China. In order to investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP.

Description:

Background: Immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease characterized by increased platelet destruction and impaired thrombopoiesis. Platelet indices changes depending on the morphology and volume of platelets. Serum lipids have been found to affect platelet formation and activity in certain diseases, thus induce the corresponding variation of platelet indices. Objectives: To investigate the correlations between platelet indices, serum lipids and bleeding symptoms in ITP. Methods: The clinical data from 457 ITP patients were retrospectively collected and analyzed, including platelet indices, serum lipids, hemorrhage and therapeutic regimen.

Recruitment information / eligibility
Status Completed
Enrollment 457
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Meet the diagnostic criteria for immune thrombocytopenia. Exclusion Criteria: - (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• ITP patients
ITP patients were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.

Locations
Country Name City State
China Qilu hospital of Shandong university Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Ming Hou

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Platelet count at 1 month after initial therapy Platelet count was tested at 1 month after initial therapy 1 month
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