RecruitingPhase 4NCT05522465

Short-course High-dose Prednisone and Dexamethasone in Children With ITP

Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia

Sponsor

Fujian Medical University Union Hospital

Enrollment

608 participants

Start Date

Oct 11, 2022

Study Type

INTERVENTIONAL

Conditions

Immune Thrombocytopenia Child, Only Glucocorticoids

Summary

Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)

Eligibility

Min Age: 29 DaysMax Age: 14 Years

Inclusion Criteria4

Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
Age > 28 days and ≤ 14 years old
Untreated PLT<20×109/L, or PLT<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
Have signed the informed consent

Exclusion Criteria7

Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and thrombopoietic drugs (recombinant human thrombopoietin, eltrombopag, etc.)
Received glucocorticoid therapy within 6 months
Menstrual female children
Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
Patients who have received radiotherapy and chemotherapy
There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.)
There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results