Evaluation of intravenous immunoglobulin versus corticosteroid in immune thrombocytopenic purpura
Phase 2
Recruiting
- Conditions
- Immune thrombocytopenic purpura (ITP).Immune thrombocytopenic purpuraD69.3
- Registration Number
- IRCT20221206056735N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Age of participants between one month and 17 years
diagnosis of ITP
The patient's plasma platelets are less than 10,000 per deciliter
Exclusion Criteria
Life-threatening bleeding
History of splenectomy
Any contraindications for receiving IVIG
A history of receiving IVIG or corticosteroids in the last two weeks (platelets have not reached more than 50,000)
Presence of co-morbidity such as sepsis
Fever above 38.5 degrees Celsius
Splenomegaly (the edge of the spleen two centimeters below the edge of the rib)
Presence of disseminated intravascular coagulation (DIC) (i.e., fibrinogen < 1 along with elevated D-dimer)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Platelet count. Timepoint: The platelet count will be measured within three intervals: 48 hours, 7 days and one month after IVIG injection. Method of measurement: Cell blood count.
- Secondary Outcome Measures
Name Time Method Bleeding symptoms. Timepoint: During hospitalization. Method of measurement: Questionnaire and physical examination by pediatric hematologist.