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Comparison of the Differences of Peripheral Blood Treg in Patients with Thrombocytopenia of Different Etiologies and the Theraputic Effect and Influence of Sirolimus on Peripheral Treg, T Subgroups and Cytokines

Comparison of the Differences of Peripheral Blood Treg in Patients with Thrombocytopenia of Different Etiologies and the Theraputic Effect and Influence of Sirolimus on Peripheral Treg, T Subgroups and Cytokines

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097006
Enrollment
Unknown
Registered
2025-02-11
Start date
2022-07-01
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune thrombocytopenia

Interventions

Healthy control group:None
Immune thrombocytopenia group:None
Connective tissue disease group:None
Connective tissue disease with thrombocytopenia group:None
Connective tissue disease complicated with refractory thrombocytopenia group:None
Hematological tumors combined with thrombocytopenia group:None

Sponsors

Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Healthy control group: 1. Age greater than 18 years old 2. Patients without connective tissue disease 3. No thrombocytopenia within 6 months at the time of enrollment (thrombocytopenia greater than 100*109/L) Idiopathic thrombocytopenia group (ITP): 1. Age greater than 18 years old 2. Newly diagnosed patients who meet the diagnostic criteria for ITP 3. Thrombocytopenia<100*109/L, medical history for more than 6 weeks Hematological malignancies with thrombocytopenia group: 1. Age greater than 18 years old 2. Meet the diagnostic criteria for hematologic tumors 3. Thrombocytopenia less than 100*109/L for more than 6 weeks Connective tissue disease with thrombocytopenia: 1. Age greater than 18 years old 2. Meet the diagnostic criteria for ACR or EULAR connective tissue disease 3. Thrombocytopenia<100*109/L, medical history for more than 6 weeks 4. Oral glucocorticoids (10-20mg/day, prednisone or equivalent) stable regimen for 4 weeks =, and the original treatment drug type and dose remain unchanged after enrollment. Connective tissue disease with refractory thrombocytopenia group 1. Age 18 years old or above 2. Meet the diagnostic criteria for ACR or EULAR connective tissue disease 3. Thrombocytopenia <50*109/L, with a medical history of more than 6 months 4. Standardized glucocorticoid treatment for 3 weeks without response or long-term maintenance of hormones exceeding the equivalent dose of more than 5mg; or at least one time of normative glucocorticoids or 1 immunosuppressant treatment after ineffective treatment and relapse after discontinuation of the drug. 5. Patients with connective tissue disease complicated with thrombocytopenia treated with oral sirolimus

Exclusion criteria

Exclusion criteria: 1. Pregnant/lactating; 2. Incomplete baseline data; 3. Combined with severely uncontrolled infected people 4. Intravenous CTX within 6 months of enrollment; Intravenous immunoglobulin or prednisone > 100 mg/day within 3 months; Calcineurin inhibitors (such as tacrolimus or cyclosporine A) for 1 month; 5. Malignant tumors 6. Patients with hepatosplenomegaly 7. Presence of other secondary thrombocytopenia diseases 8. Co-existing active or uncontrolled infections (such as tuberculosis and hepatitis) requiring the use of antibiotics or antiviral drugs; 9. Abnormal laboratory indicators: white blood cell count 1.5 times the upper limit of the laboratory reference range; Total bilirubin or blood lipids (including total cholesterol, triglycerides, low-density lipoprotein) > 2 times the upper limit of the laboratory reference range.

Design outcomes

Primary

MeasureTime frame
Treg cells;Platelet count;Subgroup T;Subgroup B;

Secondary

MeasureTime frame
Alanine aminotransferase;Serum creatinine;Potassium in the blood;

Countries

China

Contacts

Public ContactLi Xuemei

Department of Rheumatology and Allergy, Xuanwu Hospital, Capital Medical University

xuemeili353@gmail.com+86 189 1118 8326

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026