Octaplas Pediatric Plasma Replacement Trial

Inclusion Criteria:

1. Patient requiring liver or cardiac surgery and/or patient with liver dysfunction
associated with coagulopathy in whom replacement of multiple coagulation factors is
required.

2. Voluntarily given, written and signed informed consent by the patient's legal
representative(s) or guardian(s). Children deemed old enough by the
Investigator/institution to understand the risks and benefits of the study should also
be made aware of the risks/benefits of the study and provide written assent.

3. Male or female patient ≤ 16 years of age.

Exclusion Criteria:

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

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

3. Patient has an already known IgA (Immunoglobulin A) deficiency with documented
antibodies against IgA.

4. Patient has a congenital factor deficiency or platelet disorder requiring plasma
treatment.

5. Patient is currently participating in another study investigating a new drug product
or another interventional clinical study that may impact coagulation factors or has
participated during the last three (3) months.

6. Patient received FFP (Fresh Frozen Plasma), FP24 (Plasma frozen within 24 hours of
collection) or any other plasma product other than Octaplas within the last 72 hours
(cryoprecipitate and albumin are not exclusionary) prior to first Octaplas infusion.

7. Patient is on ECMO (Extracorporeal Membrane Oxygenation) when plasma is ordered by the
treating physician for the first infusion episode.

8. Patient is pregnant.

9. Patient is predicted to require massive blood transfusion defined as more than 40 mL
per kilogram of all blood products in a 24-hour period

10. Patient is receiving plasma exchange, therapeutic plasma exchange (TPE) or
plasmapheresis.

11. Patient is a premature neonate defined as less than 37 weeks gestation.

12. Cardiac surgery patients who develop the need for plasma replacement greater than 72
hours after the end of the associated cardiac surgery and do not have coagulopathy due
to hepatic dysfunction.