Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03998059

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

Evaluation of immune status before and after splenectomy in immune thrombocytopenia patients.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yunfei Chen

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

Yunfei Chen, Doctor

CONTACT

[email protected]

+86-22-23909009

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Secondary thrombocytopenic purpura;
  • Patients with poor compliance;
  • Researchers believe that patients should not participate in the test of any other condition.

Treatment and study plan

splenectomy

Procedure

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.

Primary outcomes

  1. Changes of the percentage of cell population

    Time frame: 1 year

    To assess the changes of the percentage of B cell subsets,regulatory B cells(Breg),regulatory T cells (Treg),supressor T cells(Ts),monocyte Fc receptor(FCR)I/II, FCRIII and FCRIIb, helper T cells(Th)subsets and the functionally-polarized CD4+ T cell subsets in peripheral blood mononuclear cells(PBMCs)at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.

  2. Changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs)

    Time frame: 1 year

    To assess the changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in peripheral blood mononuclear cells(PBMCs)at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.

  3. Changes of cytokines in the cell culture supernatants and plasma

    Time frame: 1 year

    To assess the changes of cytokines in the cell culture supernatants and plasma at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.

Secondary outcomes

  1. Changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.

    Time frame: The day of the splenectomy

    To assess the changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.

  2. Changes of the percentage of cell population, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls.

    Time frame: The day of the splenectomy

    To assess the changes of the percentage of B cell subsets,regulatory B cells(Breg),regulatory T cells (Treg),supressor T cells(Ts),monocyte Fc receptor(FCR)I/II, FCRIII and FCRIIb, helper T cells(Th)subsets ,the functionally-polarized CD4+ T cell subsets, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Zhang, MD

CONTACT

[email protected]

+86-22-23909240

Yunfei Chen, MD

CONTACT

[email protected]

+86-22-23909009

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Jun 25, 2019
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.