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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998059
• Other study ID #: KT2018087-EC-1
• Status: Recruiting
• Start date: January 23, 2019
• Est. completion date: July 23, 2022

Study information

• Verified date: August 2021
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Yunfei Chen, MD
• Phone: +86-22-23909009
• Email: chenyunfei[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 23, 2022
• Est. primary completion date: January 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Purpura, Thrombocytopenic, Idiopathic
• Splenectomy
• Thrombocytopenia

Intervention

Procedure:
• splenectomy
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.

Locations

Country	Name	City	State
China	Yunfei Chen	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Lei

Country where clinical trial is conducted

China, 

References & Publications (8)

Kuwana M, Okazaki Y, Kaburaki J, Kawakami Y, Ikeda Y. Spleen is a primary site for activation of platelet-reactive T and B cells in patients with immune thrombocytopenic purpura. J Immunol. 2002 Apr 1;168(7):3675-82. — View Citation

Ling Y, Cao X, Yu Z, Ruan C. Circulating dendritic cells subsets and CD4+Foxp3+ regulatory T cells in adult patients with chronic ITP before and after treatment with high-dose dexamethasome. Eur J Haematol. 2007 Oct;79(4):310-6. Epub 2007 Aug 10. — View Citation

Liu B, Zhao H, Poon MC, Han Z, Gu D, Xu M, Jia H, Yang R, Han ZC. Abnormality of CD4(+)CD25(+) regulatory T cells in idiopathic thrombocytopenic purpura. Eur J Haematol. 2007 Feb;78(2):139-43. — View Citation

McMillan R, Wang L, Tani P. Prospective evaluation of the immunobead assay for the diagnosis of adult chronic immune thrombocytopenic purpura (ITP). J Thromb Haemost. 2003 Mar;1(3):485-91. — View 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. — View Citation

Olsson B, Ridell B, Jernås M, Wadenvik H. Increased number of B-cells in the red pulp of the spleen in ITP. Ann Hematol. 2012 Feb;91(2):271-7. doi: 10.1007/s00277-011-1292-2. Epub 2011 Jul 23. — View Citation

Yu J, Heck S, Patel V, Levan J, Yu Y, Bussel JB, Yazdanbakhsh K. Defective circulating CD25 regulatory T cells in patients with chronic immune thrombocytopenic purpura. Blood. 2008 Aug 15;112(4):1325-8. doi: 10.1182/blood-2008-01-135335. Epub 2008 Apr 17. — View Citation

Zhang F, Chu X, Wang L, Zhu Y, Li L, Ma D, Peng J, Hou M. Cell-mediated lysis of autologous platelets in chronic idiopathic thrombocytopenic purpura. Eur J Haematol. 2006 May;76(5):427-31. Epub 2006 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Secondary	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.	The day of the splenectomy
Secondary	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.	The day of the splenectomy