Adverse Effects in the Therapeutic Use of Plasma Substitutes
Conditions
Keywords
Octaplas
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.
Interventions
BIOLOGICALOctaplas™
octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.
Sponsors
Octapharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
1. Patients in whom therapeutic plasma exchange (TPE) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 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 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 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. |
| 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 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 Ages 2-\<12 | 15 |
| Pediatric Patients Undergoing TPE Age Group 2 Ages 12-\<17 | 13 |
| Pediatric Patients Undergoing TPE Age Group 3 Ages ≥17 | 13 |
| Total | 41 |
Baseline characteristics
| Characteristic | Pediatric Patients Undergoing TPE Age Group 1 | Pediatric Patients Undergoing TPE Age Group 2 | Pediatric Patients Undergoing TPE Age Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 6.1 years STANDARD_DEVIATION 2.34 | 13.8 years STANDARD_DEVIATION 1.52 | 18.1 years STANDARD_DEVIATION 1.04 | 12.3 years STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 12 Participants | 12 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 9 Participants | 10 Participants | 32 Participants |
| Sex: Female, Male Female | 12 Participants | 7 Participants | 4 Participants | 23 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 15 | 0 / 13 | 0 / 13 | 1 / 41 |
| other Total, other adverse events | 0 / 15 | 3 / 13 | 1 / 13 | 4 / 41 |
| serious Total, serious adverse events | 1 / 15 | 0 / 13 | 0 / 13 | 1 / 41 |
Outcome results
Primary
Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.
Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.
Time frame: up to 8 days including the 24 hour follow-up from treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange. | 0 event |
| Pediatric Patients Undergoing TPE Age Group 2 | Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange. | 5 event |
| Pediatric Patients Undergoing TPE Age Group 3 | Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange. | 3 event |
| All Patients | Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange. | 8 event |
Primary
Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.
Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange.
Time frame: up to 8 days including the 24 hour follow-up from treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange. | 0 event |
| Pediatric Patients Undergoing TPE Age Group 2 | Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange. | 0 event |
| Pediatric Patients Undergoing TPE Age Group 3 | Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange. | 0 event |
| All Patients | Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange. | 0 event |
Secondary
Assessment of Blood Urea Nitrogen Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Blood Urea Nitrogen Levels | TPE 3 | 32.5 mg/dL | Standard Deviation 25.47 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Blood Urea Nitrogen Levels | TPE 1 | 26.4 mg/dL | Standard Deviation 18.69 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Blood Urea Nitrogen Levels | TPE 2 | 27.3 mg/dL | Standard Deviation 19.31 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Blood Urea Nitrogen Levels | TPE 4 | 28.3 mg/dL | Standard Deviation 14.38 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Blood Urea Nitrogen Levels | TPE 5 | 31.2 mg/dL | Standard Deviation 18.95 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Blood Urea Nitrogen Levels | TPE 6 | 21.0 mg/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Blood Urea Nitrogen Levels | TPE 2 | 27.6 mg/dL | Standard Deviation 18.67 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Blood Urea Nitrogen Levels | TPE 3 | 26.4 mg/dL | Standard Deviation 25.29 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Blood Urea Nitrogen Levels | TPE 4 | 28.6 mg/dL | Standard Deviation 16.21 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Blood Urea Nitrogen Levels | TPE 6 | 20.0 mg/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Blood Urea Nitrogen Levels | TPE 5 | 35.5 mg/dL | Standard Deviation 25.12 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Blood Urea Nitrogen Levels | TPE 1 | 25.2 mg/dL | Standard Deviation 18.22 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Blood Urea Nitrogen Levels | TPE 1 | -1.4 mg/dL | Standard Deviation 6.56 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Blood Urea Nitrogen Levels | TPE 5 | -0.5 mg/dL | Standard Deviation 4.36 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Blood Urea Nitrogen Levels | TPE 3 | 1.1 mg/dL | Standard Deviation 3.21 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Blood Urea Nitrogen Levels | TPE 6 | -1.0 mg/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Blood Urea Nitrogen Levels | TPE 2 | 1.2 mg/dL | Standard Deviation 4.69 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Blood Urea Nitrogen Levels | TPE 4 | 1.5 mg/dL | Standard Deviation 2.67 |
Secondary
Assessment of Carbon Dioxide Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Carbon Dioxide Levels | TPE 1 | 25.0 mmol/L | Standard Deviation 4.04 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Carbon Dioxide Levels | TPE 2 | 27.3 mmol/L | Standard Deviation 3.58 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Carbon Dioxide Levels | TPE 3 | 26.2 mmol/L | Standard Deviation 3.13 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Carbon Dioxide Levels | TPE 4 | 26.3 mmol/L | Standard Deviation 3.13 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Carbon Dioxide Levels | TPE 5 | 27.3 mmol/L | Standard Deviation 4.32 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Carbon Dioxide Levels | TPE 6 | 29.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Carbon Dioxide Levels | TPE 6 | 32.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Carbon Dioxide Levels | TPE 1 | 26.9 mmol/L | Standard Deviation 4.62 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Carbon Dioxide Levels | TPE 4 | 26.6 mmol/L | Standard Deviation 4.87 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Carbon Dioxide Levels | TPE 5 | 27.0 mmol/L | Standard Deviation 7.75 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Carbon Dioxide Levels | TPE 2 | 28.2 mmol/L | Standard Deviation 3.96 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Carbon Dioxide Levels | TPE 3 | 26.7 mmol/L | Standard Deviation 2.33 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Carbon Dioxide Levels | TPE 2 | 0.5 mmol/L | Standard Deviation 2.79 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Carbon Dioxide Levels | TPE 3 | 1.2 mmol/L | Standard Deviation 1.72 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Carbon Dioxide Levels | TPE 6 | 3.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Carbon Dioxide Levels | TPE 4 | 1.0 mmol/L | Standard Deviation 2.98 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Carbon Dioxide Levels | TPE 1 | 2.2 mmol/L | Standard Deviation 3.03 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Carbon Dioxide Levels | TPE 5 | 0.3 mmol/L | Standard Deviation 5.5 |
Secondary
Assessment of Chloride Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Chloride Levels | TPE 6 | 111.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Chloride Levels | TPE 3 | 106.7 mmol/L | Standard Deviation 5.28 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Chloride Levels | TPE 5 | 103.0 mmol/L | Standard Deviation 5.22 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Chloride Levels | TPE 1 | 105.0 mmol/L | Standard Deviation 4.24 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Chloride Levels | TPE 4 | 106.4 mmol/L | Standard Deviation 7.06 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Chloride Levels | TPE 2 | 105.5 mmol/L | Standard Deviation 4.44 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Chloride Levels | TPE 4 | 106.8 mmol/L | Standard Deviation 6.98 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Chloride Levels | TPE 5 | 104.8 mmol/L | Standard Deviation 7.93 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Chloride Levels | TPE 2 | 105.4 mmol/L | Standard Deviation 5.04 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Chloride Levels | TPE 6 | 108.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Chloride Levels | TPE 1 | 105.2 mmol/L | Standard Deviation 5.15 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Chloride Levels | TPE 3 | 107.5 mmol/L | Standard Deviation 6.15 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Chloride Levels | TPE 6 | -3.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Chloride Levels | TPE 1 | 0.5 mmol/L | Standard Deviation 3.31 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Chloride Levels | TPE 2 | 0.6 mmol/L | Standard Deviation 2.72 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Chloride Levels | TPE 3 | -0.3 mmol/L | Standard Deviation 2.37 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Chloride Levels | TPE 4 | -0.9 mmol/L | Standard Deviation 2.59 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Chloride Levels | TPE 5 | 1.0 mmol/L | Standard Deviation 6.78 |
Secondary
Assessment of Creatinine Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Creatinine Levels | TPE 5 | 1.1 mg/dl | Standard Deviation 0.66 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Creatinine Levels | TPE 3 | 1.1 mg/dl | Standard Deviation 0.78 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Creatinine Levels | TPE 4 | 1.0 mg/dl | Standard Deviation 0.51 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Creatinine Levels | TPE 6 | 0.8 mg/dl | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Creatinine Levels | TPE 2 | 1.3 mg/dl | Standard Deviation 1 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Creatinine Levels | TPE 1 | 1.7 mg/dl | Standard Deviation 2.24 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Creatinine Levels | TPE 3 | 0.9 mg/dl | Standard Deviation 0.84 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Creatinine Levels | TPE 1 | 1.3 mg/dl | Standard Deviation 1.45 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Creatinine Levels | TPE 2 | 1.2 mg/dl | Standard Deviation 0.95 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Creatinine Levels | TPE 4 | 0.9 mg/dl | Standard Deviation 0.59 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Creatinine Levels | TPE 5 | 1.2 mg/dl | Standard Deviation 0.87 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Creatinine Levels | TPE 6 | 0.8 mg/dl | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Creatinine Levels | TPE 2 | -0.1 mg/dl | Standard Deviation 0.31 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Creatinine Levels | TPE 6 | 0.0 mg/dl | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Creatinine Levels | TPE 5 | 0.1 mg/dl | Standard Deviation 0.09 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Creatinine Levels | TPE 3 | -0.1 mg/dl | Standard Deviation 0.22 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Creatinine Levels | TPE 1 | -0.4 mg/dl | Standard Deviation 1.1 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Creatinine Levels | TPE 4 | 0.0 mg/dl | Standard Deviation 0.09 |
Secondary
Assessment of Erythrocyte Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Erythrocyte Levels | TPE 1 | 4.0 10^12 cells/L | Standard Deviation 0.7 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Erythrocyte Levels | TPE 2 | 3.6 10^12 cells/L | Standard Deviation 0.6 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Erythrocyte Levels | TPE 3 | 3.6 10^12 cells/L | Standard Deviation 0.7 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Erythrocyte Levels | TPE 4 | 3.7 10^12 cells/L | Standard Deviation 0.67 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Erythrocyte Levels | TPE 5 | 3.9 10^12 cells/L | Standard Deviation 0.96 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Erythrocyte Levels | TPE 6 | 2.9 10^12 cells/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Erythrocyte Levels | TPE 6 | 2.8 10^12 cells/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Erythrocyte Levels | TPE 1 | 4.1 10^12 cells/L | Standard Deviation 0.81 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Erythrocyte Levels | TPE 4 | 3.4 10^12 cells/L | Standard Deviation 0.71 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Erythrocyte Levels | TPE 5 | 3.2 10^12 cells/L | Standard Deviation 0.35 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Erythrocyte Levels | TPE 2 | 3.7 10^12 cells/L | Standard Deviation 0.68 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Erythrocyte Levels | TPE 3 | 3.8 10^12 cells/L | Standard Deviation 0.6 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Erythrocyte Levels | TPE 2 | 0.1 10^12 cells/L | Standard Deviation 0.27 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Erythrocyte Levels | TPE 3 | 0.1 10^12 cells/L | Standard Deviation 0.26 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Erythrocyte Levels | TPE 6 | -0.1 10^12 cells/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Erythrocyte Levels | TPE 4 | 0.1 10^12 cells/L | Standard Deviation 0.17 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Erythrocyte Levels | TPE 1 | 0.1 10^12 cells/L | Standard Deviation 0.26 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Erythrocyte Levels | TPE 5 | -0.1 10^12 cells/L | Standard Deviation 0.49 |
Secondary
Assessment of Glucose Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Glucose Levels | TPE 3 | 141.9 mg/dl | Standard Deviation 65.12 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Glucose Levels | TPE 1 | 144.7 mg/dl | Standard Deviation 70.1 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Glucose Levels | TPE 4 | 191.0 mg/dl | Standard Deviation 142.81 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Glucose Levels | TPE 6 | 77.0 mg/dl | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Glucose Levels | TPE 2 | 138.2 mg/dl | Standard Deviation 61.92 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Glucose Levels | TPE 5 | 147.2 mg/dl | Standard Deviation 85.33 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Glucose Levels | TPE 2 | 142.7 mg/dl | Standard Deviation 75.86 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Glucose Levels | TPE 1 | 135.2 mg/dl | Standard Deviation 41.89 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Glucose Levels | TPE 3 | 156.9 mg/dl | Standard Deviation 57.67 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Glucose Levels | TPE 4 | 142.1 mg/dl | Standard Deviation 59.04 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Glucose Levels | TPE 5 | 140.8 mg/dl | Standard Deviation 61.7 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Glucose Levels | TPE 6 | 75.0 mg/dl | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Glucose Levels | TPE 2 | 12.5 mg/dl | Standard Deviation 44.76 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Glucose Levels | TPE 6 | -2.0 mg/dl | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Glucose Levels | TPE 5 | 15.8 mg/dl | Standard Deviation 38.59 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Glucose Levels | TPE 3 | 22.6 mg/dl | Standard Deviation 45.69 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Glucose Levels | TPE 1 | -12.0 mg/dl | Standard Deviation 65.83 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Glucose Levels | TPE 4 | -44.3 mg/dl | Standard Deviation 158.61 |
Secondary
Assessment of Hematocrit Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hematocrit Levels | TPE 1 | 34.1 % of the blood that is red blood cells | Standard Deviation 5.31 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hematocrit Levels | TPE 2 | 31.7 % of the blood that is red blood cells | Standard Deviation 4.75 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hematocrit Levels | TPE 3 | 31.0 % of the blood that is red blood cells | Standard Deviation 4.98 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hematocrit Levels | TPE 4 | 31.7 % of the blood that is red blood cells | Standard Deviation 4.29 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hematocrit Levels | TPE 5 | 32.9 % of the blood that is red blood cells | Standard Deviation 5.73 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hematocrit Levels | TPE 6 | 27.7 % of the blood that is red blood cells | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hematocrit Levels | TPE 6 | 26.1 % of the blood that is red blood cells | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hematocrit Levels | TPE 1 | 35.6 % of the blood that is red blood cells | Standard Deviation 6.44 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hematocrit Levels | TPE 4 | 30.2 % of the blood that is red blood cells | Standard Deviation 5.5 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hematocrit Levels | TPE 5 | 28.8 % of the blood that is red blood cells | Standard Deviation 2.95 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hematocrit Levels | TPE 2 | 32.8 % of the blood that is red blood cells | Standard Deviation 5.24 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hematocrit Levels | TPE 3 | 33.3 % of the blood that is red blood cells | Standard Deviation 5 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hematocrit Levels | TPE 2 | 0.8 % of the blood that is red blood cells | Standard Deviation 2.39 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hematocrit Levels | TPE 3 | 1.0 % of the blood that is red blood cells | Standard Deviation 2.37 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hematocrit Levels | TPE 6 | -1.6 % of the blood that is red blood cells | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hematocrit Levels | TPE 4 | 0.6 % of the blood that is red blood cells | Standard Deviation 1.25 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hematocrit Levels | TPE 1 | 1.1 % of the blood that is red blood cells | Standard Deviation 2.12 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hematocrit Levels | TPE 5 | -1.2 % of the blood that is red blood cells | Standard Deviation 4.03 |
Secondary
Assessment of Hemoglobin Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hemoglobin Levels | TPE 1 | 11.5 g/dL | Standard Deviation 1.94 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hemoglobin Levels | TPE 2 | 10.7 g/dL | Standard Deviation 1.79 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hemoglobin Levels | TPE 3 | 10.4 g/dL | Standard Deviation 1.9 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hemoglobin Levels | TPE 4 | 10.6 g/dL | Standard Deviation 1.61 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hemoglobin Levels | TPE 5 | 10.9 g/dL | Standard Deviation 2.13 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Hemoglobin Levels | TPE 6 | 8.7 g/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hemoglobin Levels | TPE 6 | 8.3 g/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hemoglobin Levels | TPE 1 | 12.1 g/dL | Standard Deviation 2.22 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hemoglobin Levels | TPE 4 | 9.9 g/dL | Standard Deviation 1.94 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hemoglobin Levels | TPE 5 | 9.4 g/dL | Standard Deviation 1.06 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hemoglobin Levels | TPE 2 | 11.0 g/dL | Standard Deviation 2.03 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Hemoglobin Levels | TPE 3 | 11.2 g/dL | Standard Deviation 2.03 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hemoglobin Levels | TPE 2 | 0.3 g/dL | Standard Deviation 0.74 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hemoglobin Levels | TPE 3 | 0.3 g/dL | Standard Deviation 0.7 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hemoglobin Levels | TPE 6 | -0.4 g/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hemoglobin Levels | TPE 4 | -0.1 g/dL | Standard Deviation 0.67 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hemoglobin Levels | TPE 1 | 0.4 g/dL | Standard Deviation 0.74 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Hemoglobin Levels | TPE 5 | -0.5 g/dL | Standard Deviation 1.44 |
Secondary
Assessment of Leukocyte Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Leukocyte Levels | TPE 6 | 3.7 10^9 cells/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Leukocyte Levels | TPE 3 | 13.2 10^9 cells/L | Standard Deviation 6.49 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Leukocyte Levels | TPE 5 | 8.7 10^9 cells/L | Standard Deviation 3.17 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Leukocyte Levels | TPE 1 | 12.8 10^9 cells/L | Standard Deviation 6.84 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Leukocyte Levels | TPE 4 | 10.8 10^9 cells/L | Standard Deviation 6.32 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Leukocyte Levels | TPE 2 | 14.9 10^9 cells/L | Standard Deviation 7.45 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Leukocyte Levels | TPE 4 | 12.7 10^9 cells/L | Standard Deviation 6.4 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Leukocyte Levels | TPE 5 | 10.7 10^9 cells/L | Standard Deviation 3.65 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Leukocyte Levels | TPE 2 | 15.3 10^9 cells/L | Standard Deviation 6.43 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Leukocyte Levels | TPE 6 | 7.0 10^9 cells/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Leukocyte Levels | TPE 1 | 13.6 10^9 cells/L | Standard Deviation 7.45 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Leukocyte Levels | TPE 3 | 13.9 10^9 cells/L | Standard Deviation 7.2 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Leukocyte Levels | TPE 6 | 3.3 10^9 cells/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Leukocyte Levels | TPE 1 | 0.9 10^9 cells/L | Standard Deviation 3.8 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Leukocyte Levels | TPE 2 | 1.2 10^9 cells/L | Standard Deviation 3.93 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Leukocyte Levels | TPE 3 | -0.5 10^9 cells/L | Standard Deviation 2.44 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Leukocyte Levels | TPE 4 | 1.2 10^9 cells/L | Standard Deviation 1.14 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Leukocyte Levels | TPE 5 | 1.6 10^9 cells/L | Standard Deviation 1.55 |
Secondary
Assessment of Mean Corpuscular Hemoglobin Concentration Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 1 | 33.6 g/dL | Standard Deviation 1.38 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 2 | 33.6 g/dL | Standard Deviation 1.35 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 3 | 33.4 g/dL | Standard Deviation 2.17 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 4 | 33.2 g/dL | Standard Deviation 1.16 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 5 | 33.1 g/dL | Standard Deviation 1.75 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 6 | 31.4 g/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 6 | 31.8 g/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 1 | 33.9 g/dL | Standard Deviation 1.2 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 4 | 32.6 g/dL | Standard Deviation 1.19 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 5 | 32.6 g/dL | Standard Deviation 1.21 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 2 | 33.6 g/dL | Standard Deviation 1.58 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 3 | 33.5 g/dL | Standard Deviation 1.43 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 2 | 0 g/dL | Standard Deviation 0.97 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 3 | -0.2 g/dL | Standard Deviation 0.91 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 6 | 0.4 g/dL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 4 | -0.8 g/dL | Standard Deviation 1.15 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 1 | 0.1 g/dL | Standard Deviation 0.75 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | TPE 5 | -0.5 g/dL | Standard Deviation 0.62 |
Secondary
Assessment of Mean Corpuscular Hemoglobin Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 1 | 29.0 pg | Standard Deviation 2.54 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 2 | 29.6 pg | Standard Deviation 2.47 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 3 | 29.2 pg | Standard Deviation 2.19 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 4 | 28.9 pg | Standard Deviation 2.41 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 5 | 28.3 pg | Standard Deviation 2.74 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 6 | 29.8 pg | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 6 | 29.6 pg | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 1 | 29.4 pg | Standard Deviation 2.18 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 4 | 29.2 pg | Standard Deviation 1.5 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 5 | 29.4 pg | Standard Deviation 1.75 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 2 | 30.2 pg | Standard Deviation 2.48 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 3 | 29.4 pg | Standard Deviation 1.31 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 2 | 0.1 pg | Standard Deviation 0.77 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 3 | -0.2 pg | Standard Deviation 0.58 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 6 | -0.2 pg | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 4 | -0.8 pg | Standard Deviation 1.18 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 1 | 0.1 pg | Standard Deviation 0.7 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Hemoglobin Levels | TPE 5 | -0.4 pg | Standard Deviation 0.31 |
Secondary
Assessment of Mean Corpuscular Volume Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Volume Levels | TPE 1 | 86.4 fL | Standard Deviation 6.96 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Volume Levels | TPE 2 | 88.1 fL | Standard Deviation 7.46 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Volume Levels | TPE 3 | 88.2 fL | Standard Deviation 11.38 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Volume Levels | TPE 4 | 87.0 fL | Standard Deviation 7.9 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Volume Levels | TPE 5 | 85.9 fL | Standard Deviation 9.3 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Corpuscular Volume Levels | TPE 6 | 95.0 fL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Volume Levels | TPE 6 | 93.0 fL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Volume Levels | TPE 1 | 86.8 fL | Standard Deviation 6.68 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Volume Levels | TPE 4 | 89.9 fL | Standard Deviation 6.78 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Volume Levels | TPE 5 | 90.2 fL | Standard Deviation 7.02 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Volume Levels | TPE 2 | 90.0 fL | Standard Deviation 6.91 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Corpuscular Volume Levels | TPE 3 | 87.8 fL | Standard Deviation 3.57 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Volume Levels | TPE 2 | 0.3 fL | Standard Deviation 1.55 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Volume Levels | TPE 3 | -0.1 fL | Standard Deviation 1.55 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Volume Levels | TPE 6 | -2.0 fL | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Volume Levels | TPE 4 | -0.3 fL | Standard Deviation 2.01 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Volume Levels | TPE 1 | 0.2 fL | Standard Deviation 1.21 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Corpuscular Volume Levels | TPE 5 | -0.1 fL | Standard Deviation 2.13 |
Secondary
Assessment of Mean Ionized Calcium Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Ionized Calcium Levels | TPE 1 | 1.225 mmol/L | Standard Deviation 0.0731 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Ionized Calcium Levels | TPE 2 | 1.212 mmol/L | Standard Deviation 0.0678 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Ionized Calcium Levels | TPE 3 | 1.165 mmol/L | Standard Deviation 0.2119 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Ionized Calcium Levels | TPE 4 | 1.205 mmol/L | Standard Deviation 0.0763 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Ionized Calcium Levels | TPE 5 | 1.200 mmol/L | Standard Deviation 0.0452 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Ionized Calcium Levels | TPE 6 | 1.248 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Ionized Calcium Levels | TPE 5 | 1.240 mmol/L | Standard Deviation 0.1039 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Ionized Calcium Levels | TPE 6 | 1.148 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Ionized Calcium Levels | TPE 1 | 1.129 mmol/L | Standard Deviation 0.1541 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Ionized Calcium Levels | TPE 3 | 1.181 mmol/L | Standard Deviation 0.1062 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Ionized Calcium Levels | TPE 4 | 1.265 mmol/L | Standard Deviation 0.106 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Ionized Calcium Levels | TPE 2 | 1.192 mmol/L | Standard Deviation 0.1224 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Ionized Calcium Levels | TPE 4 | 0.062 mmol/L | Standard Deviation 0.0805 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Ionized Calcium Levels | TPE 5 | 0.040 mmol/L | Standard Deviation 0.064 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Ionized Calcium Levels | TPE 1 | -0.093 mmol/L | Standard Deviation 0.1583 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Ionized Calcium Levels | TPE 3 | 0.020 mmol/L | Standard Deviation 0.1696 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Ionized Calcium Levels | TPE 2 | -0.001 mmol/L | Standard Deviation 0.0967 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Ionized Calcium Levels | TPE 6 | -0.100 mmol/L | Standard Deviation 0 |
| All Patients | Assessment of Mean Ionized Calcium Levels | TPE 4 | 1.204 mmol/L | Standard Deviation 0.0666 |
| All Patients | Assessment of Mean Ionized Calcium Levels | TPE 2 | 1.204 mmol/L | Standard Deviation 0.0832 |
| All Patients | Assessment of Mean Ionized Calcium Levels | TPE 3 | 1.224 mmol/L | Standard Deviation 0.0926 |
| All Patients | Assessment of Mean Ionized Calcium Levels | TPE 6 | 1.173 mmol/L | Standard Deviation 0 |
| All Patients | Assessment of Mean Ionized Calcium Levels | TPE 5 | 1.168 mmol/L | Standard Deviation 0.0948 |
| All Patients | Assessment of Mean Ionized Calcium Levels | TPE 1 | 1.194 mmol/L | Standard Deviation 0.0852 |
| Change From Pre-TPE to Follow-Up | Assessment of Mean Ionized Calcium Levels | TPE 5 | -0.032 mmol/L | Standard Deviation 0.1089 |
| Change From Pre-TPE to Follow-Up | Assessment of Mean Ionized Calcium Levels | TPE 3 | 0.026 mmol/L | Standard Deviation 0.0684 |
| Change From Pre-TPE to Follow-Up | Assessment of Mean Ionized Calcium Levels | TPE 2 | 0.026 mmol/L | Standard Deviation 0.1203 |
| Change From Pre-TPE to Follow-Up | Assessment of Mean Ionized Calcium Levels | TPE 6 | -0.075 mmol/L | Standard Deviation 0 |
| Change From Pre-TPE to Follow-Up | Assessment of Mean Ionized Calcium Levels | TPE 4 | 0.011 mmol/L | Standard Deviation 0.0995 |
| Change From Pre-TPE to Follow-Up | Assessment of Mean Ionized Calcium Levels | TPE 1 | -0.030 mmol/L | Standard Deviation 0.0927 |
Secondary
Assessment of Mean Red Cell Distribution Width Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Red Cell Distribution Width Levels | TPE 1 | 14.4 % red blood cell variation volume/size | Standard Deviation 2.66 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Red Cell Distribution Width Levels | TPE 2 | 14.6 % red blood cell variation volume/size | Standard Deviation 2.83 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Red Cell Distribution Width Levels | TPE 3 | 15.2 % red blood cell variation volume/size | Standard Deviation 3.18 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Red Cell Distribution Width Levels | TPE 4 | 16.2 % red blood cell variation volume/size | Standard Deviation 3.1 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Red Cell Distribution Width Levels | TPE 5 | 17.1 % red blood cell variation volume/size | Standard Deviation 3.04 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Mean Red Cell Distribution Width Levels | TPE 6 | 18.2 % red blood cell variation volume/size | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Red Cell Distribution Width Levels | TPE 6 | 18.0 % red blood cell variation volume/size | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Red Cell Distribution Width Levels | TPE 1 | 13.9 % red blood cell variation volume/size | Standard Deviation 1.94 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Red Cell Distribution Width Levels | TPE 4 | 16.5 % red blood cell variation volume/size | Standard Deviation 3.1 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Red Cell Distribution Width Levels | TPE 5 | 18.6 % red blood cell variation volume/size | Standard Deviation 3.24 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Red Cell Distribution Width Levels | TPE 2 | 15.0 % red blood cell variation volume/size | Standard Deviation 3.02 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Mean Red Cell Distribution Width Levels | TPE 3 | 15.0 % red blood cell variation volume/size | Standard Deviation 2.31 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Red Cell Distribution Width Levels | TPE 2 | 0.1 % red blood cell variation volume/size | Standard Deviation 0.37 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Red Cell Distribution Width Levels | TPE 3 | -0.1 % red blood cell variation volume/size | Standard Deviation 0.33 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Red Cell Distribution Width Levels | TPE 6 | -0.2 % red blood cell variation volume/size | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Red Cell Distribution Width Levels | TPE 4 | 0.0 % red blood cell variation volume/size | Standard Deviation 0.25 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Red Cell Distribution Width Levels | TPE 1 | 0.0 % red blood cell variation volume/size | Standard Deviation 0.26 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Mean Red Cell Distribution Width Levels | TPE 5 | 0.3 % red blood cell variation volume/size | Standard Deviation 0.52 |
Secondary
Assessment of Potassium Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Potassium Levels | TPE 3 | 3.7 mmol/L | Standard Deviation 0.57 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Potassium Levels | TPE 1 | 3.9 mmol/L | Standard Deviation 0.57 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Potassium Levels | TPE 4 | 4.1 mmol/L | Standard Deviation 0.62 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Potassium Levels | TPE 2 | 3.9 mmol/L | Standard Deviation 0.43 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Potassium Levels | TPE 6 | 4.2 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Potassium Levels | TPE 5 | 3.9 mmol/L | Standard Deviation 0.3 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Potassium Levels | TPE 2 | 4.0 mmol/L | Standard Deviation 0.47 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Potassium Levels | TPE 1 | 3.8 mmol/L | Standard Deviation 0.58 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Potassium Levels | TPE 3 | 3.9 mmol/L | Standard Deviation 0.36 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Potassium Levels | TPE 4 | 4.0 mmol/L | Standard Deviation 0.64 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Potassium Levels | TPE 5 | 3.8 mmol/L | Standard Deviation 0.37 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Potassium Levels | TPE 6 | 3.5 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Potassium Levels | TPE 2 | 0.1 mmol/L | Standard Deviation 0.26 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Potassium Levels | TPE 6 | -0.7 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Potassium Levels | TPE 5 | -0.1 mmol/L | Standard Deviation 0.61 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Potassium Levels | TPE 3 | 0.1 mmol/L | Standard Deviation 0.49 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Potassium Levels | TPE 1 | -0.1 mmol/L | Standard Deviation 0.54 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Potassium Levels | TPE 4 | -0.2 mmol/L | Standard Deviation 0.65 |
Secondary
Assessment of Sodium Levels
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.
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received blood draws/multiple TPEs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Sodium Levels | TPE 6 | 142.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Sodium Levels | TPE 3 | 141.2 mmol/L | Standard Deviation 3.87 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Sodium Levels | TPE 5 | 138.8 mmol/L | Standard Deviation 3.19 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Sodium Levels | TPE 1 | 140.0 mmol/L | Standard Deviation 3.66 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Sodium Levels | TPE 4 | 140.7 mmol/L | Standard Deviation 4.64 |
| Pediatric Patients Undergoing TPE Age Group 1 | Assessment of Sodium Levels | TPE 2 | 141.2 mmol/L | Standard Deviation 3.28 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Sodium Levels | TPE 4 | 142.4 mmol/L | Standard Deviation 5.13 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Sodium Levels | TPE 5 | 141.3 mmol/L | Standard Deviation 3.86 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Sodium Levels | TPE 2 | 142.3 mmol/L | Standard Deviation 4.41 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Sodium Levels | TPE 6 | 144.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Sodium Levels | TPE 1 | 141.6 mmol/L | Standard Deviation 3.23 |
| Pediatric Patients Undergoing TPE Age Group 2 | Assessment of Sodium Levels | TPE 3 | 142.9 mmol/L | Standard Deviation 5.07 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Sodium Levels | TPE 3 | 1.5 mmol/L | Standard Deviation 2.84 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Sodium Levels | TPE 1 | 1.6 mmol/L | Standard Deviation 2.41 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Sodium Levels | TPE 2 | 1.5 mmol/L | Standard Deviation 1.84 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Sodium Levels | TPE 6 | 2.0 mmol/L | Standard Deviation 0 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Sodium Levels | TPE 4 | 0.8 mmol/L | Standard Deviation 1.75 |
| Pediatric Patients Undergoing TPE Age Group 3 | Assessment of Sodium Levels | TPE 5 | 1.0 mmol/L | Standard Deviation 2.16 |
Secondary
Investigator's Assessment of Overall Safety
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
Time frame: up to 8 days including the 24 hour follow-up
Population: Not all patients received multiple TPEs
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 1 | Excellent | 37 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 1 | Moderate | 4 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 1 | Poor | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 2 | Excellent | 25 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 2 | Moderate | 1 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 2 | Poor | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 3 | Excellent | 18 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 3 | Moderate | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 3 | Poor | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 4 | Excellent | 9 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 4 | Moderate | 1 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 4 | Poor | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 5 | Excellent | 6 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 5 | Moderate | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 5 | Poor | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 6 | Excellent | 1 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 6 | Moderate | 0 Participants |
| Pediatric Patients Undergoing TPE Age Group 1 | Investigator's Assessment of Overall Safety | Patients Who Underwent TPE 6 | Poor | 0 Participants |