Octaplas Pediatric Plasma Replacement Trial
Condition: Liver Surgery; Liver Dysfunction; Coagulopathy; Cardiac Surgery
MeSH terms: Liver Diseases
Intervention: octaplas
Intervention description: Octaplas S/D Plasma
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Pediatric; patients; replacement; coagulation factors; plasma; s/d plasma; Octaplas; plasma replacement

Summary:

      The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas
      in pediatric patients who require replacement of multiple coagulation factors. Replacement of
      multiple coagulation factors in pediatric patients with acquired deficiencies due to liver
      disease and/or in pediatric patients requiring cardiac surgery or liver surgery.
    

Eligibility criteria:

        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.