Clinical trial NCT03998059: Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
Official title: Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombocytopenia
Splenectomy
Keywords: Thrombocytopenia
splenectomy
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The ITP patients who are eligible for inclusion, but not eligible for exclusion, will be included in the clinical trials.

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of the percentage of cell population
timeFrame: 1 year
measure: Changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs)
timeFrame: 1 year
measure: Changes of cytokines in the cell culture supernatants and plasma
timeFrame: 1 year
Secondary outcomes:
measure: Changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.
timeFrame: The day of the splenectomy
measure: 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.
timeFrame: The day of the splenectomy
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Yunfei Chen
state: Tianjin
Study officials:
affiliation: Chinese Academy of Medical Science and Blood Disease Hospital
name: Lei Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Olsson B, Ridell B, Carlsson L, Jacobsson S, Wadenvik H. Recruitment of T cells into bone marrow of ITP patients possibly due to elevated expression of VLA-4 and CX3CR1. Blood. 2008 Aug 15;112(4):1078-84. doi: 10.1182/blood-2008-02-139402. Epub 2008 Jun 2.
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