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

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

Sponsors

Lead Sponsor: Zhang Lei

Source Institute of Hematology & Blood Diseases Hospital
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.

Overall Status Recruiting
Start Date January 23, 2019
Completion Date July 23, 2022
Primary Completion Date January 23, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Changes of the percentage of cell population 1 year
Changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) 1 year
Changes of cytokines in the cell culture supernatants and plasma 1 year
Secondary Outcome
Measure Time Frame
Changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls. The day of the splenectomy
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. The day of the splenectomy
Enrollment 50
Condition
Intervention

Intervention Type: Procedure

Intervention Name: splenectomy

Description: 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.

Arm Group Label: 30 immune thrombocytopenia(ITP) patients

Eligibility

Sampling Method: Non-Probability Sample

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Lei Zhang, MD Principal Investigator Chinese Academy of Medical Science and Blood Disease Hospital
Overall Contact

Last Name: Yunfei Chen, MD

Phone: +86-22-23909009

Email: [email protected]

Location
Facility: Status: Contact: Yunfei Chen Yunfei Chen, Doctor +86-22-23909009 [email protected]
Location Countries

China

Verification Date

July 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Institute of Hematology & Blood Diseases Hospital

Investigator Full Name: Zhang Lei

Investigator Title: vice Director of Thrombosis and Hemostasis Center

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 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

Label: 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.

Label: 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.

Label: 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.

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov