Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment
Conditions
Brief summary
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate
Interventions
DRUGintravenous immunoglobulin
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia
Sponsors
The First Affiliated Hospital of Xiamen University
Zhangzhou Affiliated Hospital of Fujian Medical University
Quanzhou First Hospital
Nanping First Hospital Affiliated to Fujian Medical University
The Second Hospital of Anhui Medical University
The Affiliated Hospital Of Guizhou Medical University
Longyan City First Hospital
The Affiliated Hospital of Putian University
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Days to 14 Years
Healthy volunteers
No
Inclusion criteria
Subjects enrolled in this study must meet all of the following criteria: 1. Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment 2. Age \> 28 days and ≤ 14 years old 3. PLT\<20×109/L 4. Have signed the informed consent
Exclusion criteria
Anyone who has any of the following conditions will not enter the clinical study: 1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy 2. Received glucocorticoid or IVIG therapy within 6 months 3. Weight \> 40kg 4. Menstrual female patients 5. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases 6. Patients who have received radiotherapy and chemotherapy 7. 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| early response to treatment | 7 days after treatment | Platelet counts after 7 days of IVIG treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Economic Indicators | 1 week | Calculate the total amount of IVIG used in 1 week (weight normalized) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 1 week | Incidence of Treatment-Emergent Adverse Events in 1 week |
Countries
China
Contacts
Primary ContactShaohua Le, Master's degree
Outcome results
None listed