Recruiting

Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cytopenia+2

+ Blood Platelet Disorders

+ Hematologic Diseases

From 18 to 60 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: January 2019
See protocol details

Summary

Principal SponsorInstitute of Hematology & Blood Diseases Hospital, China
Study ContactYunfei Chen, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 23, 2019

Actual date on which the first participant was enrolled.

A total of 30 ITP patients will be enrolled in the study. These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy. Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital. The investigators plan to take 20ml of peripheral blood (PB) of these patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and take a small amount of spleen tissue during surgery. 18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood. The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to Hereditary spherocytosis or trauma. And then the investigators will do the experiments step by step. 1, Isolation of peripheral blood and splenic mononuclear cells;2, Detection of the percentage of cell population;3, Activation and proliferation of B lymphocyte; 4, Activation and proliferation of T lymphocyte;5,Apoptosis of platelets by cytotoxic T cells;6,Phagocytosis of platelets by macrophages in spleen;7,Enzyme-linked immunosorbent assay (ELISA) for cytokines.

Official TitleEvaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
NCT03998059
Principal SponsorInstitute of Hematology & Blood Diseases Hospital, China
Study ContactYunfei Chen, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombocytopenia

Criteria

4 inclusion criteria required to participate
Aged 18 to 60 years old, male or female;

Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)

Needed splenectomy;

People who are willing to sign the informed consent voluntarily and follow the research program.

3 exclusion criteria prevent from participating
Secondary thrombocytopenic purpura;

Patients with poor compliance;

Researchers believe that patients should not participate in the test of any other condition.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Yunfei Chen

Tianjin, ChinaOpen Yunfei Chen in Google Maps
Recruiting
One Study Center