Leukocytosis
Conditions
Keywords
white blood cell depletion, apheresis
Brief summary
This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.
Detailed description
The goal of this study is to gather a broader knowledge and information from routine clinical use on the performance and safety of white blood cell depletion procedures with the Spectra Optia® apheresis system. In order to do so, retrospective data on white blood cell depletion procedures with the Spectra Optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.
Interventions
DEVICESpectra Optia® Apheresis System
White Blood Cell Depletion
Sponsors
Terumo BCT
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure | Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100% |
| Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia. | immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure | Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume) |
| Adverse Events | Participants were followed for the duration of the procedure and for up to 24 hours after the procedure. | Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's Platelet Count Post-depletion Procedure | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | Patient's platelet count post-depletion procedure |
| Whole Blood Processed (mL) | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | Volume of patient's blood processed in mL during the apheresis procedure |
| Whole Blood Flow mL/Min | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | Whole Blood Flow in mL/min measured during the white blood cell depletion procedure |
| Pre-procedure WBC Count | Prior to Each Spectra Optia Apheresis Procedure | Pre-procedure WBC count |
| Platelet Change (% Change) | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | % change in patient's pre and post-depletion procedure platelet counts |
| Waste Bag Volume | Post each Spectra Optia Apheresis Procedure | Volume of the depletion product |
| Procedure Duration | Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours. | The duration of the WBCD procedure measured in minutes |
| Post-procedure WBC Count | Following apheresis procedure | Post-procedure WBC count |
| Patient's Platelet Count Pre-depletion Procedure | Prior to Each Spectra Optia Apheresis Procedure | Patient's platelet count pre-depletion procedure |
Countries
Belgium, Germany, Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Who Received At Least 1 WBCD Apheresis Procedure Eligible subjects who received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Subjects Who Received At Least 1 WBCD Apheresis Procedure | — |
|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 17.1 | — |
| Height | 170.9 cm STANDARD_DEVIATION 10.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 9 participants | — |
| Region of Enrollment Germany | 11 participants | — |
| Region of Enrollment Hungary | 23 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 27 Participants | — |
| Total Blood Volume | 4.7 Liters STANDARD_DEVIATION 0.8 | — |
| Weight | 73.2 kg STANDARD_DEVIATION 16.7 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 32 |
| other Total, other adverse events | 37 / 43 | 30 / 32 |
| serious Total, serious adverse events | 0 / 43 | 1 / 32 |
Outcome results
Primary
Adverse Events
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.
Time frame: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.
Population: Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, \< 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| WBCD Procedures Performed | Adverse Events | 37 Number of subjects with at least 1 TEAE |
| Safety Data Collection 0-24 Hours Post Apheresis Procedure | Adverse Events | 30 Number of subjects with at least 1 TEAE |
Primary
Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.
Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)
Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Population: The CE of the WBCD procedures was measured from the waste bag (depletion product) contents from Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia. | 58.7 percent of processed WBCs | Standard Deviation 16.1 |
Primary
Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%
Time frame: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Population: The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected. One patient terminated the first procedure prematurely and therefore did not have post-procedure data, resulting in a total of 57 units analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure | 54.5 % change in subject's WBC count | Standard Deviation 21.4 |
Other Pre-specified
Patient's Platelet Count Post-depletion Procedure
Patient's platelet count post-depletion procedure
Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Population: Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Patient's Platelet Count Post-depletion Procedure | 59.5 cells x 10^3/L | Standard Deviation 53.5 |
Other Pre-specified
Patient's Platelet Count Pre-depletion Procedure
Patient's platelet count pre-depletion procedure
Time frame: Prior to Each Spectra Optia Apheresis Procedure
Population: Full and Safety Analysis Sets.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Patient's Platelet Count Pre-depletion Procedure | 88.1 cells x 10^3/L | Standard Deviation 75.58 |
Other Pre-specified
Platelet Change (% Change)
% change in patient's pre and post-depletion procedure platelet counts
Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Population: Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Platelet Change (% Change) | 20.8 percent change | Standard Deviation 62.15 |
Other Pre-specified
Post-procedure WBC Count
Post-procedure WBC count
Time frame: Following apheresis procedure
Population: Data were collected on a total of 58 procedures, however one patient terminated the first procedure prematurely and therefore did not have post-procedure data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Post-procedure WBC Count | 119.9 cells x 10^9/L | Standard Deviation 156.05 |
Other Pre-specified
Pre-procedure WBC Count
Pre-procedure WBC count
Time frame: Prior to Each Spectra Optia Apheresis Procedure
Population: The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Pre-procedure WBC Count | 243.5 cells x 10^9/L | Standard Deviation 175.6 |
Other Pre-specified
Procedure Duration
The duration of the WBCD procedure measured in minutes
Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Population: Full and Safety Analysis Sets
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Procedure Duration | 237.3 minutes | Standard Deviation 97.38 |
Post Hoc
Total Blood Volumes (TBV) Processed
Number of times the patient's TBV was processed during the apheresis procedure based on the patient's estimated TBV (Estimated by Nadler's formula for total blood volume of a human being based on gender, height, and weight).
Time frame: Post each Spectra Optia Apheresis Procedure
Population: Full and Safety Analysis Sets
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Total Blood Volumes (TBV) Processed | 2.5 TBV | Standard Deviation 0.9 |
Other Pre-specified
Waste Bag Volume
Volume of the depletion product
Time frame: Post each Spectra Optia Apheresis Procedure
Population: Full and Safety Analysis Sets; One patient terminated the first procedure prematurely, resulting in a total of 57 units analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Waste Bag Volume | 1371.2 mL | Standard Deviation 896.2 |
Other Pre-specified
Whole Blood Flow mL/Min
Whole Blood Flow in mL/min measured during the white blood cell depletion procedure
Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Population: Full and Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Whole Blood Flow mL/Min | 50.3 mL/min | Standard Deviation 12.8 |
Other Pre-specified
Whole Blood Processed (mL)
Volume of patient's blood processed in mL during the apheresis procedure
Time frame: Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.
Population: Full and Safety Analysis Sets
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WBCD Procedures Performed | Whole Blood Processed (mL) | 11395 mL | Standard Deviation 4010 |