A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.
Immune Thrombocytopenic Purpura
About this trial
This is an interventional treatment trial for Immune Thrombocytopenic Purpura focused on measuring Thrombocytopenia, pediatric, methylprednisolone, intracranial hemorrhage, intravenous immune globulin
Eligibility Criteria
Inclusion Criteria:
- ages 1-17 yr. followed at participating centers
- diagnosed with primary ITP
- present with a PC < 20 x 10^9/L
- patient and attending physician have decided on treatment of ITP
Exclusion Criteria:
- initial presentation with ITP
- splenectomy
- life-threatening hemorrhage e.g. proven or suspected intracranial hemorrhage (ICH), major gastrointestinal hemorrhage with cardiorespiratory decompensation
- organ-threatening hemorrhage e.g. hemorrhage into the eye
- contraindication to IVIG ( renal disease with creatinine > x 2 upper list of normal )
- contraindication of IV methylprednisolone ( diabetes mellitus, hypertension, peptic ulceration )
- prior failure to attain a PC level over 50 X 109 within 2 weeks of treatment with IVIG of 0.8 to 1 g/kg or IV methyl-prednisolone (max 1 gram ) within 6 months prior to study entry
- co-existing situations that could affect platelet response to therapy e.g. sepsis, fever > 38.5°C ( orally or equivalent), splenomegaly (spleen tip > 2 cm below costal margin), Disseminated Intravascular Coagulation (DIC) - defined by a fibrinogen level < 1.0 g/dL and elevated D-dimer levels, surgery
- pregnancy (a mandatory urine pregnancy test will be obtained on all post-pubescent female patients). Such patients can only be eligible once the urine pregnancy test results are confirmed to be negative.
Sites / Locations
- Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Placebo and IVIG
Methylprednisolone and IVIG
The trial site is blinded to the randomization process. Patients are assigned an arm by a research pharmacist. Patients on this arm receive an infusion of placebo (0.9% NaCl) over one hour. Immediately following this dosing, 1 g/kg IVIG (Gammunex ©) is infused over 2 - 3 hours. Following this treatment, complete blood counts are drawn at: completion of IVIG infusion, 8 hours following the start of the placebo/solumedrol infusion 24 hours following the start of the placebo/solumedrol infusion 72 hours following the start of the placebo/solumedrol infusion 7 days post infusion 21 days post infusion
The trial site is blinded to the randomization process. Patients are assigned an arm by a research pharmacist.Patients on this arm receive IV Methylprednisolone 30 mg/kg (1 gram maximum) infused over one hour. Immediately following this dosing, 1 g/kg IVIG Gammunex © is infused over 2 - 3 hours. Following this treatment, complete blood counts are drawn at: completion of IVIG infusion, 8 hours following the start of the placebo/solumedrol infusion 24 hours following the start of the placebo/solumedrol infusion 72 hours following the start of the placebo/solumedrol infusion 7 days post infusion 21 days post infusion