A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
Childhood immune thrombocytopenia purpura (ITP) is a disorder characterized by the production
of antibodies against platelets, resulting in enhanced destruction of platelets. Most
children with ITP present with low platelet counts (PC) but minimal bleeding. Very rarely a
child may present with a severe life-threatening bleed, such as a bleed in the head. In this
case it is very important that the PC be raised as quickly as possible. The combination of
corticosteroids and intravenous gammaglobulin (IVIG) is commonly used in the management of
such severe bleeding in children with ITP to quickly raise the PC and yet this treatment
combination has not been tested against using IVIG alone. If it is shown that the combination
of these agents does result in a quicker rise in PC then when using IVIG alone would support
the use of this combination therapy in emergency situations.
As we can not ethically conduct this study in patients with life-threatening bleeds, we plan
to study patients with ITP and PC less than 20 X 109/L, but without life threatening
bleeding. Eligible patients will be randomized to one of these 2 regimens (IVIG + placebo or
IVIG + IV corticosteroids). The study is designed as a double-blind trial, where the patient
or the treating physician will not be aware of the regimen that a patient is randomized to.
PC's will be measured as a surrogate measure of bleeding risk; bleeding scores (a score
generated by observing patients for bleeding symptoms) will be used to grade bleeding
severity, and adverse effects to treatment will be monitored by the means of questionnaires
throughout the study.