Octaplas Pediatric Plasma Replacement Trial

Phase 4

Completed

Conditions: Coagulopathy
Cardiac Surgery
Liver Surgery
Liver Dysfunction

Interventions: Biological: octaplas

Registration Number: NCT02050841

Lead Sponsor: Octapharma

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patient requiring liver or cardiac surgery and/or patient with liver dysfunction associated with coagulopathy in whom replacement of multiple coagulation factors is required.
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.
Male or female patient ≤ 16 years of age.

Exclusion Criteria

Patient with known homozygous congenital deficiency of protein S.
Patient has a history of hypersensitivity reaction to blood or plasma-derived products or to any excipient of the investigational product.
Patient has an already known IgA (Immunoglobulin A) deficiency with documented antibodies against IgA.
Patient has a congenital factor deficiency or platelet disorder requiring plasma treatment.
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.
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.
Patient is on ECMO (Extracorporeal Membrane Oxygenation) when plasma is ordered by the treating physician for the first infusion episode.
Patient is pregnant.
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
Patient is receiving plasma exchange, therapeutic plasma exchange (TPE) or plasmapheresis.
Patient is a premature neonate defined as less than 37 weeks gestation.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Octaplas	octaplas	Qualified patients will receive Octaplas as per protocol.

Primary Outcome Measures

Name	Time	Method
Monitoring of Clinically Significant Changes in White Blood Cells	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Hemoglobin	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Platelets	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)	up to 6 days
Monitoring of Clinically Significant Changes in Hematocrit	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1
Monitoring of Clinically Significant Changes in Red Blood Cells	up to 6 days	Assesses Pre- and Post-infusion for Infusion Episode 1

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)	up to 6 days	This hemostatic parameter is figured out in the lab and helps to diagnose a bleeding disorder or excessive clotting disorder. The change of INR before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)	up to 6 days	aPTT measures the length of time (in seconds) that it takes for clotting to occur in a test cube. The higher the number of seconds the longer it takes the blood to clot. The changes between pre - and post infusion were analyzed
Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.	up to 6 days	Normal infusion: Replacement of multiple clotting factors Bypass priming: Limit hemodilution and reduce transfusion requirements Bypass warming up: Rewarm patients suffering from hypothermia during the surgery process
Medically Significant Changes in Respiratory Rate	up to 6 days
Medically Significant Changes in Oxygen Saturation	up to 6 days
Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')	up to 6 days
Medically Significant Changes in Blood Pressure	up to 6 days
Medically Significant Changes in Heart Rate	up to 6 days
Medically Significant Changes in Body Temperature	up to 6 days
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)	up to 6 days	This hemostatic parameter is figured out in the lab and measures the time it takes for your blood to clot (the higher the PT the longer it takes your blood to clot). The change of PT before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.
Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).	up to 6 days	TEG and ROTEM are methods of testing the efficiency of blood coagulation. The results were compared by looking at potential trends from TEG and ROTEM between pre-infusion vs post-infusion time points.