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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • splenectomy

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 4 treatment groups
Group A: 30 immune thrombocytopenia(ITP) patients1 intervention
Group B: 20 normal controls0 interventions
Group C: Spleens of the 30 cases patients(ITP)0 interventions
Group D: Spleens of the 10 cases patients(normal controls)0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.

Time frame
1 year
3

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
The day of the splenectomy
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.

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.

Time frame
The day of the splenectomy

Other outcomes

Sponsors and contacts

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