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

The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

The primary objective for the IgG adsorber GLOBAFFIN® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.

Inclusion criteria

• Minimum age of 18 years
• Informed consent signed and dated by study patient and investigator/authorised physician
• Ability to understand the nature and requirements of the study
• Treatment with one of the immunoadsorber system GLOBAFFIN® according to the intended use.

Exclusion criteria

General:

• Any condition which could interfere with the patient's ability to comply with the study
• In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old 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 active substances (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 immunoadsorber column or the extracorporeal circuit
• Inability to withstand the stress of an extracorporeal treatment procedure due to their 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 to heparin or ACD-A
• Haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard
• Severe cardiovascular disease, so that extracorporeal treatment is not possible
• Acute, systemic infection