Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine

Inclusion Criteria:

• Minimum age of 18 years

• Informed consent signed and dated by study patient and investigator/authorisedphysician

• Ability to understand the nature and requirements of the study

• Treatment with one of the immunoadsorber system GLOBAFFIN® according to the intendeduse.

Exclusion Criteria:

General:

• Any condition which could interfere with the patient's ability to comply with thestudy

• In case of female patients: pregnancy or lactation period (if patient is ≥ 55 yearsold or have been surgically sterilized, a negative pregnancy test is not required)

• Participation in an interventional clinical study during the preceding 30 days.

• Participation in an interventional clinical study with pharmacological activesubstances (e.g. therapeutic antibodies) during the preceding 60 days.

• Any deviation from the intended use

Study-specific:

Any contraindication listed in the valid instruction for use:

• Hypersensitivity or allergy against any materials used in either the immunoadsorbercolumn or the extracorporeal circuit

• Inability to withstand the stress of an extracorporeal treatment procedure due totheir age, their physical developments or their clinical constitution

• Previously demonstrated hypersensitivity associated with therapeutic apheresis

• No suitable anticoagulation treatment, such as due to known hypersensitivity toheparin or ACD-A

• Haemorrhagic diathesis in which extracorporeal apheresis procedures andanticoagulation performed have a high bleeding hazard

• Severe cardiovascular disease, so that extracorporeal treatment is not possible

• Acute, systemic infection