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

Institute of Hematology & Blood Diseases Hospital, China

Status: Enrolling

Conditions: Thrombocytopenia; Splenectomy

Treatments: Procedure: splenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03998059

KT2018087

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 4 patient groups

30 immune thrombocytopenia(ITP) patients

Description:

A total of 30 cases. The investigators plan to take 20ml of peripheral blood (PB) of these 30 ITP patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery

Treatment:

Procedure: splenectomy

20 normal controls

Description:

A total of 20 cases.18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood.

Spleens of the 30 cases patients(ITP)

Description:

These 30 ITP patients agree to have splenectomy.The investigators will take a small amount of spleen tissue during surgery.

Spleens of the 10 cases patients(normal controls)

Description:

The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to hereditary spherocytosis or trauma.