Evaluating immune status in patients with low platelet counts before and after spleen removal
Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
This study is trying to see how removing the spleen affects the immune system in people with low platelet counts who haven't found relief from other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT03998059 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the immune status of patients with immune thrombocytopenia (ITP) before and after undergoing splenectomy. A total of 30 patients who have not responded to multiple treatments will be enrolled, and their platelet levels will be stabilized prior to surgery. Blood samples will be collected at various time points around the surgery to assess changes in immune cell populations and functions. Additionally, spleen tissue will be collected during the procedure for further analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 diagnosed with immune thrombocytopenia who require splenectomy.
Not a fit: Patients with secondary thrombocytopenic purpura or those with poor compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the immune mechanisms involved in ITP and improve treatment strategies for patients with this condition.
How similar studies have performed: While there have been studies on splenectomy in ITP, this specific evaluation of immune status before and after the procedure is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Secondary thrombocytopenic purpura; * Patients with poor compliance; * Researchers believe that patients should not participate in the test of any other condition.
Where this trial is running
Tianjin, Tianjin Municipality
- Yunfei Chen — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Lei Zhang, MD — Chinese Academy of Medical Science and Blood Disease Hospital
- Study coordinator: Yunfei Chen, MD
- Email: chenyunfei@ihcams.ac.cn
- Phone: +86-22-23909009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.