Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of immune status before and after splenectomy in immune thrombocytopenia patients.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 immune thrombocytopenia(ITP) patients | 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 |
| |
| 20 normal controls | 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) | 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) | The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to hereditary spherocytosis or trauma. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| splenectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The ITP patients who are eligible for inclusion, but not eligible for exclusion, will be included in the clinical trials.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunfei Chen, MD | Contact | +86-22-23909009 | chenyunfei@ihcams.ac.cn | |
| Lei Zhang, MD | Contact | +86-22-23909240 | zhanglei1@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, MD | Chinese Academy of Medical Science and Blood Disease Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yunfei Chen | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21785982 | Background | Olsson B, Ridell B, Jernas 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. | |
| 11907134 | Background | 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. doi: 10.4049/jimmunol.168.7.3675. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| D013156 | Splenectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| 16480433 | Background | 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. doi: 10.1111/j.1600-0609.2005.00622.x. Epub 2006 Feb 15. |
| 17328716 | Background | 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. doi: 10.1111/j.1600-0609.2006.00780.x. |
| 17692100 | Background | 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. doi: 10.1111/j.1600-0609.2007.00917.x. Epub 2007 Aug 10. |
| 18519809 | Background | 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. |
| 12871454 | Background | 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. doi: 10.1046/j.1538-7836.2003.00091.x. |
| 18420827 | Background | 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. |