Efficacy and Safety of IVIG-L in ITP Patients

Inclusion Criteria: Patients with chronic ITP with a platelet count of about 20x109/L and at high risk of bleeding Patients with chronic ITP with a platelet count of about 20x109/L, who have to undergo surgery A stable clinical situation (no activity of any other disease) Age at least 18 yrs The patient/legally acceptable representative has signed the consent form Exclusion Criteria: The presence of another autoimmune disease related with thrombocytopenia such as systematic lupus erythematosus (SLE), rheumatoid arthritis (RA) or nephritis Patients with drug-induced thrombocytopenia or immunologic thrombocytopenia of infectious origin (in particular, Hepatitis, Epstein-Barr virus, Toxoplasma, HIV) Massive splenomegaly Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study Having an ongoing progressive terminal disease, including HIV infection Known with allergic reactions against human plasma, plasma products or intravenous immunoglobulin Presence of conditions predisposing for bleeding: anaemia (hemoglobin < 5.5 mmol/L), renal or urogenital disease, malignant disease (with the exception of basalioma, cervix carcinoma in situ), history of intracranial or aortic aneurysm, stroke, oeso-gastro-intestinal disorders with a bleeding potential, severe hypertension (diastole > 110 mm Hg). Use of corticosteroids for an acute situation within 7 days before study entry. Patients using corticosteroids prophylactically can be included Splenectomy in the previous two weeks Renal insufficiency (plasma creatinine > 115µmol/L) Pregnancy or lactation Known with insufficiency of coronary or cerebral circulation IgA deficiency and anti-IgA antibodies