Thrombocytopenia
Conditions
Keywords
ITP
Brief summary
Proportion who would avoid splenectomy at 6 months of follow up
Detailed description
1. If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week. Second line Helicobacter pylori eradication will be permitted after failure of first line treatment. 2. Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2) 3. Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.
Interventions
OTHERSteroid refractory ITP
a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
Sponsors
Cooperative Study Group A for Hematology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.ITP is defined by * (a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia * 2.Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis) * 3.Steroid refractory ITP: a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks) * 4.18 years old or more
Exclusion criteria
* 1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug * 2.Pregnancy * 3.Splectomized patients * 4.Rh- blood type * 5.Hemoglobin \< 10g/dL * 6.Known hypersensitivity to immunoglobulins * 7.A positive direct antiglobulin test * 8.Clinically relevant hepatic or renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion who would avoid splenectomy at 6 months of follow up | 2years | Proportion who would avoid splenectomy at 6 months of follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SR,IR | 2years | Sustained response (platelet count that remained above 30X109/L or 2 folds of initial platelet count at 6 months of follow up) Initial response (an increase in the platelet count of at least 10X109/L or a platelet count of more than 30X109/L by day 7 after the initiation of treatment) Changes of platelet counts Safety of treatment Response rate of HP infected patients Decrement of steroid dose Predictors of response |
Countries
South Korea
Contacts
Primary ContactSung-Hwa Bae, professor
Outcome results
None listed