About this trial
Evaluation of immune status before and after splenectomy in immune thrombocytopenia patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Secondary thrombocytopenic purpura;
Patients with poor compliance;
Researchers believe that patients should not participate in the test of any other condition.
Trial population
The ITP patients who are eligible for inclusion, but not eligible for exclusion, will be included in the clinical trials.
Trial design
Case-control
Prospective
Treatments tested in this trial
splenectomy
Procedure/SurgeryThese 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.
Treatment groups
Trial outcomes
Primary outcomes
Changes of the percentage of cell population
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.
Changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs)
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.
Changes of cytokines in the cell culture supernatants and plasma
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
Changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.
To assess the changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.
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.
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.
Sponsors and contacts
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