Autoimmune hemolytic anemia
Conditions
Interventions
Treatment group:Rituximab was added within 4 weeks
Control group:Rituximab was added after 4 weeks
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1) Age <=18 years old; 2) AIHA was confirmed by bone marrow morphology, DAT, blood routine, reticulocyte count, bilirubin, etc; 3) No history of rituximab treatment; 4) The following criteria were met before admission: the first attack of hemolysis, clinical manifestations of hemolysis after high-dose glucocorticoids and intravenous human immunoglobulin impact treatment, hemoglobin less than 100g/L; Severe clinical manifestations of acute hemolytic anemia, such as systemic or circulatory failure; Any one of the above two items can be satisfied; 5) There is no contraindication to drug treatment; 6) Long-term follow-up at the diagnosis and treatment center can be guaranteed; 7) All parents/guardians of the selected children voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Rituximab was used in the past; 2) Any significant abnormal comorbidities or mental illnesses that affect the patient's life safety and compliance, informed consent, study participation, follow-up, or interpretation of results; 3) The child or guardian cannot be followed up, or the compliance is poor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months ORR (CR+PR) rate;safety capability evaluation (Incidence of adverse reactions); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hormone therapy;ORR (CR+PR) rate at 12 months of treatment; | — |
Countries
China
Contacts
Public ContactJin Jiang
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed