Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
NCT ID: NCT03998059
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2019-01-23
2025-07-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
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.
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with poor compliance;
* Researchers believe that patients should not participate in the test of any other condition.
18 Years
60 Years
ALL
Yes
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Principal Investigators
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Lei Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Science and Blood Disease Hospital
Locations
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Yunfei Chen
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KT2018087
Identifier Type: -
Identifier Source: org_study_id
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