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

NCT03998059 | Recruiting

• 1 other identifier: KT2018087
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thrombocytopenia; Splenectomy

Keywords

Thrombocytopenia; splenectomy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• 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

Study Arms (4)

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

Procedure: splenectomy

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.

Interventions

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.

30 immune thrombocytopenia(ITP) patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The ITP patients who are eligible for inclusion, but not eligible for exclusion, will be included in the clinical trials.

You may qualify if:

• 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.

You may not qualify if:

• Secondary thrombocytopenic purpura;
• Patients with poor compliance;
• Researchers believe that patients should not participate in the test of any other condition.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Yunfei Chen

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 21785982 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.

  PMID: 11907134 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.

  PMID: 16480433 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.

  PMID: 17328716 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.

  PMID: 17692100 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.

  PMID: 18519809 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.

  PMID: 12871454 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.

  PMID: 18420827 BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Splenectomy

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Lei Zhang, MD

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunfei Chen, MD

CONTACT

+86-22-23909009; chenyunfei@ihcams.ac.cn

Lei Zhang, MD

CONTACT

+86-22-23909240; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 25, 2019
• Study Start: January 23, 2019
• Primary Completion: January 23, 2022
• Study Completion: July 23, 2025
• Last Updated: February 24, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)