Skip to content

Comparison of the effect of Intravenous immunoglobulin and rhophylac

Comparison of the effect of Intravenous immunoglobulin and rhophylac in treatment of immune thrombocytopenic purpura

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012102811289N1
Enrollment
60
Registered
2013-12-13
Start date
2012-08-05
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Idiopathic thrombocytopenic purpura. Idiopathic thrombocytopenic purpura (Evans syndrome)

Interventions

Intervention 1: Intervention 1. IVIG, 1 gr/kg, 8 hours IV infusion, single dose. Intervention 2: Intervention 2. Rhophylac, 50 µg/kg, 15 minutes IV infusion with 100 ml normal saline, single dose.
Treatment - Drugs
Intervention 1. IVIG, 1 gr/kg, 8 hours IV infusion, single dose.
Intervention 2. Rhophylac, 50 µg/kg, 15 minutes IV infusion with 100 ml normal saline, single dose.

Sponsors

Arak University of Medical Sciences, Vice Chancellor for Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Age upper 1 year and lower 15 years old in patients with acute or chronic ITP 2. Platelets <30000 at the time of treatment 3. Patients entered in the study that parental consent was obtained Exclusion criteria: 1. Splenectomy patients 2. Hemoglobin below 10 g/dL 3. Patients who have been treated with IVIG or rhophylac in the past three weeks 4. Patients with renal insufficiency 5. Total bilirubin above 2 mg per deciliter and higher than normal liver enzymes 6. Patients who have a positive direct Coombs test 7. Patients who are infected with HIV or hepatitis C or B 8. Patients with lupus erythematosus 9. Patients with cardiovascular disease 10. Rh-negative patients

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Platelet count. Timepoint: Sixth hour and days 3, 7, and 14 after treatment. Method of measurement: complete blood count.;Fever. Timepoint: since 6 hours after infusion. Method of measurement: mercury thermometer.;Hemolysis. Timepoint: 6 hours after infusion. Method of measurement: complete blood count.;Allergic reaction. Timepoint: 6 hours after infusion. Method of measurement: clinical manifestations.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Peyman Azadmanesh

Arak University of Medical Sciences

dr.azadmanesh@arakmu.ac.ir+98 86 3312 0180

Outcome results

None listed

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