Trial Information

Prospective Assessment of 0.2 um Pore-sized Filters in Preventing Intravenous Immunoglobulin-associated Adverse Reactions

Prospective single center study with an observational phase (phase A) and a randomized
intervention-phase (phase B), monitoring adverse events and complement activation after IVIG
infusion. Patients would be enrolled at the Out-patient Clinic of the Division of Hematology
at the Department of Internal Medicine at the University Hospital Basel (USB). Based on the
number of patients receiving IVIG at the Division of Hematology of the USB we expect to be
able to complete data accrual within 8-10 months.

Inclusion criteria: all patients at the Division of Hematology at the University Hospital of
Basel, Switzerland after allogeneic stem cell transplant and older than 18 years which are
planed for at least 2 applications of IVIG. The patients are included in this study only by
informed consent.

Methods: Side effects of IVIG will be monitored by use of a standardized questionnaire
distributed to the nursing staff and the patients (please see attachment). Complement
activation will be monitored before and after the IVIG-infusion using standard C3, C4 and
50% complement hemolytic activity (CH50) assays. Serum levels of immunoglobulin A,
immunoglobulin M and immunoglobulin G will be quantified before and after IVIG-infusion. In
phase A of the study we aim at including approximately 40 patients (which would be predicted
to include approximately 20 patients with clinical symptoms). In phase B we would randomize
these same patients into two groups of similar sizes, the first group receiving standard
unfiltered IVIG infusions, the second group receiving 0.2um filtered IVIG infusions