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Evaluation of intravenous immunoglobulin versus corticosteroid in immune thrombocytopenic purpura

Efficacy of a single dose of Intravenous immune globulin (IVIG) (0.8 gr/Kg) vs tab Prednisolone (2mg/Kg) in pediatric newly diagnosed Immune thrombocytopenia (ITP)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221206056735N1
Enrollment
100
Registered
2022-12-19
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune thrombocytopenic purpura (ITP). Immune thrombocytopenic purpura

Interventions

Intervention 1: Intervention group: group receiving intravenous immunoglobulin: In this group, participants receive intravenous immunoglobulin at a dose of 0.8 mg per kilogram of the patient's weight

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 17 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Bleeding symptoms. Timepoint: During hospitalization. Method of measurement: Questionnaire and physical examination by pediatric hematologist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud Khodaei

Shahid Beheshti University of Medical Sciences

Surgery1353@gmail.com+98 21 7772 5483

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026