Octaplas Pediatric Plasma Exchange Trial

Phase 4

Completed

Conditions: Adverse Effects in the Therapeutic Use of Plasma Substitutes

Interventions: Biological: Octaplas™

Registration Number: NCT01938378

Lead Sponsor: Octapharma

Brief Summary: To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric patients who require therapeutic plasma exchange.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Patients in whom therapeutic plasma exchange (TPE) is required.
Patient is male or female ≥ 2 years to ≤ 20 years of age.
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

Patient with known homozygous congenital deficiency of Protein S.

Exclusion Criteria:
Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product.
Patient has an already known IgA deficiency with documented antibodies against IgA.
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. Concurrent participation in a device study will be considered on a case by case basis.
Patient is pregnant.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric patients undergoing TPE	Octaplas™	octaplas™

Primary Outcome Measures

Name	Time	Method
Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.	up to 8 days including the 24 hour follow-up from treatment	Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.
Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.	up to 8 days including the 24 hour follow-up from treatment	Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange.

Secondary Outcome Measures

Name	Time	Method
Assessment of Carbon Dioxide Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Chloride Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Sodium Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Erythrocyte Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Hematocrit Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Leukocyte Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Blood Urea Nitrogen Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Creatinine Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Potassium Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Mean Corpuscular Hemoglobin Concentration Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Glucose Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Hemoglobin Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Mean Corpuscular Volume Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Mean Corpuscular Hemoglobin Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.
Assessment of Mean Ionized Calcium Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange), during each TPE, and after each TPE. Pre-TPE is within 24 hours before TPE start; Follow-Up is 24 (+/-2) hours after TPE end.
Investigator's Assessment of Overall Safety	up to 8 days including the 24 hour follow-up	Excellent: defined as the treatment was well tolerated by the patient; Moderate: defined as Adverse Drug Reaction (ADR(s)) were observed, but easily resolved or not clinically significant; Poor: defined as ADR(s) were observed requiring significant medical intervention
Assessment of Mean Red Cell Distribution Width Levels	up to 8 days including the 24 hour follow-up	Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.