Octaplas Pediatric Plasma Exchange Trial

Inclusion Criteria:

1. Patients in whom therapeutic plasma exchange is required.

2. Patient is male or female ≥ 2 years to ≤ 20 years of age.

3. Patient or patient's legal representative(s)/guardian(s) has /have given voluntarily
written and signed informed consent before any study-related procedure is to be
performed. If children are old enough (age usually deemed by each institution) to
understand the risks and benefits of the study, they should also be informed and
provide their written assent.

Exclusion Criteria:

1. Patient with known homozygous congenital deficiency of Protein S.

Exclusion Criteria:

2. Patient has a history of severe hypersensitivity reaction to plasma-derived products
or to any excipient of the investigational product.

3. Patient has an already known IgA deficiency with documented antibodies against IgA.

4. Patient is currently participating in another interventional clinical study or has
participated during the past 1 month prior to study inclusion. This is not applicable
to non-interventional trials and does not exclude patients who have been exposed to
Investigational Medicinal Product with a washout of at least 30 days from enrollment
in LAS-213

5. Patient is pregnant.

6. Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the
first infusion episode or planned used of these medications while on study.