NCT05095896

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

2.9 years

First QC Date

September 30, 2021

Last Update Submit

October 14, 2021

Conditions

Keywords

immune thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Platelet count at 1 month after initial therapy

    Platelet count was tested at 1 month after initial therapy

    1 month

Interventions

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 457 ITP patients at Department of Hematology of Qilu Hospital 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.

You may qualify if:

  • Meet the diagnostic criteria for immune thrombocytopenia.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital of Shandong university

Jinan, Shandong, 273300, China

Location

Related Publications (1)

  • Xu P, Han S, Hou M, Zhao Y, Xu M. The serum lipid profiles in immune thrombocytopenia: Mendelian randomization analysis and a retrospective study. Thromb J. 2023 Oct 13;21(1):107. doi: 10.1186/s12959-023-00551-x.

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Manager

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 27, 2021

Study Start

January 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 27, 2021

Record last verified: 2021-10

Locations