Actively Recruiting

Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID03998059

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

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24

50

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the immune status before and after splenectomy in patients with immune thrombocytopenia (ITP) who have not had a lasting response to multiple treatments. The study involves 30 ITP patients who still meet the diagnosis criteria before surgery, and it also includes healthy donors and patients with splenectomy due to other causes as control groups. The purpose is to better understand immune changes related to splenectomy in this condition. The study involves laparoscopic splenectomy performed on the 30 ITP patients after raising their platelet levels to a safe state. Blood samples will be collected from these patients at six time points: one day before surgery, then 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. A small amount of spleen tissue will be taken during surgery. Healthy donors and patients with splenectomy for hereditary spherocytosis or trauma will also provide blood or spleen tissue samples for comparison. Participants will have blood drawn multiple times to analyze immune cell populations, activation and proliferation of B and T lymphocytes, platelet apoptosis by cytotoxic T cells, macrophage phagocytosis of platelets, and cytokine levels using laboratory tests such as ELISA. The study will monitor immune changes for one year after splenectomy. The total involvement includes pre-surgery assessment, surgery, and follow-up blood tests at specified intervals to measure immune responses and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 60 years old, male or female
  • Diagnosed with immune thrombocytopenia (ITP)
  • Scheduled for splenectomy
  • Willing to sign informed consent and follow the study program
Not Eligible

You will not qualify if you...

  • Secondary thrombocytopenic purpura
  • Poor compliance
  • Any other condition deemed by researchers to prevent participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Pre-Surgery Assessments

Duration - Up to 1 day before surgery

Participants have their platelet levels raised to a safe state before undergoing splenectomy and provide a blood sample 1 day before surgery.

1 visit (in-person) for blood collection and pre-surgery assessment

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo laparoscopic splenectomy during which a small amount of spleen tissue is collected for study purposes.

1 visit (in-person) for surgery and tissue collection

Post-operative Follow-up and Sample Collection

Duration - 12 months following surgery

Participants provide blood samples at 1 week, 1 month, 3 months, 6 months, and 12 months after surgery to monitor immune status.

5 visits (in-person) for blood collection at scheduled intervals after surgery

Trial Site Locations

Total: 1 location

1

Yunfei Chen

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

Y

Yunfei Chen, MD

L

Lei Zhang, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Spleen is a primary site for activation of platelet-reactive T and B cells in patients with immune thrombocytopenic purpura.

Masataka Kuwana, Yuka Okazaki, Junichi Kaburaki...

https://pubmed.ncbi.nlm.nih.gov/11907134

Circulating dendritic cells subsets and CD4+Foxp3+ regulatory T cells in adult patients with chronic ITP before and after treatment with high-dose dexamethasome.

Yun Ling, Xiangshan Cao, Ziqiang Yu...

https://pubmed.ncbi.nlm.nih.gov/17692100