Defective circulating CD25 regulatory T cells in patients with chronic immune thrombocytopenic purpura.
Jin Yu, Susanne Heck, Vivek Patel...
https://pubmed.ncbi.nlm.nih.gov/18420827/Actively Recruiting
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
50
Participants Needed
1
Research Sites
182 weeks
Total Duration
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
Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
Y
Yunfei Chen, MD
L
Lei Zhang, MD
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Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Lead Sponsor