Myeloproliferative Disease, Thrombocythemia, Thrombocytosis
Conditions
Keywords
platelet depletion, apheresis
Brief summary
Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
Detailed description
This is a multicenter, retrospective data collection to evaluate the in routine use performance and safety of platelet depletions performed via the Spectra Optia system. Data collection will include procedures in 2- 3 different centers in Europe done between November 2011 and April 2014.
Interventions
Platelet 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 one platelet depletion procedure via the Spectra Optia system. * Availability of complete blood count results prior to starting and after completing the platelet depletion procedure via the Spectra Optia system.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure | on average this will be within 15 minutes after the end of the procedure | (PLTpre - PLTpost) / PLTpre x 100% |
| Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia. | on average this will be within 15 minutes after the end of the procedure | (PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume) |
| Adverse Events | during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure). | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's WBC Count Post-depletion Procedure | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | — |
| Whole Blood Processed (mL) | Post each Spectra Optia Apheresis Procedure | Volume of patients blood processed during the apheresis procedure. |
| Average Inlet Flow Rate | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | — |
| Patient's Platelet Count Pre-depletion Procedure | Prior to each Spectra Optia Apheresis Procedure | — |
| Waste Bag Volume | Post each Spectra Optia Apheresis Procedure | — |
| Total Blood Volume (TBV) Processed | Post each Spectra Optia Apheresis Procedure | The number of times the patient's total blood volume is processed during the apheresis procedure. |
| Procedure Duration | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | — |
| Patient's Platelet Count Post-depletion Procedure | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | — |
| Patients WBC Count Pre-depletion Procedure | Prior to each Spectra Optia Apheresis Procedure | — |
Countries
Denmark, Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Age, Customized Age (years) | 64.3 years STANDARD_DEVIATION 13 |
| Diagnosis Chronic myeloid leukaemia | 1 pariticpants |
| Diagnosis Essential thrombocythaemia | 9 pariticpants |
| Diagnosis Myelodysplastic/myeloproliferative neoplasm | 1 pariticpants |
| Diagnosis Polycythaemia vera | 1 pariticpants |
| Height | 163.9 cm STANDARD_DEVIATION 9.2 |
| Region of Enrollment Denmark | 3 participants |
| Region of Enrollment Hungary | 9 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
| Total Blood Volume | 4.0 Liters STANDARD_DEVIATION 0.7 |
| Weight | 63.6 kg STANDARD_DEVIATION 13.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Adverse Events
Time frame: during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).
Population: Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Adverse Events | 6 Number of subjects with at least 1 AE |
Primary
Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
(PLTpre - PLTpost) / PLTpre x 100%
Time frame: on average this will be within 15 minutes after the end of the procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure | -58.2 % change in PLT count in subject blood | Standard Deviation 12 |
Primary
Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.
(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)
Time frame: on average this will be within 15 minutes after the end of the procedure
Population: At Site 2, percent processed platelets could only be calculated for 1 procedure in Subject 214; no waste bag (depletion product) platelet counts were available for the other 9 procedures performed at Site 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia. | 67.8 % of processed platelets | Standard Deviation 18.3 |
Other Pre-specified
Average Inlet Flow Rate
Time frame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Average Inlet Flow Rate | 46.7 mL/min | Standard Deviation 8.45 |
Other Pre-specified
Patient's Platelet Count Post-depletion Procedure
Time frame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Patient's Platelet Count Post-depletion Procedure | 717.2 cells x 10^3/L | Standard Deviation 336 |
Other Pre-specified
Patient's Platelet Count Pre-depletion Procedure
Time frame: Prior to each Spectra Optia Apheresis Procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Patient's Platelet Count Pre-depletion Procedure | 1740.7 cells x 10^3/L | Standard Deviation 744.95 |
Other Pre-specified
Patient's WBC Count Post-depletion Procedure
Time frame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Patient's WBC Count Post-depletion Procedure | 8.4 cells x 10^9/L | Standard Deviation 6.66 |
Other Pre-specified
Patients WBC Count Pre-depletion Procedure
Time frame: Prior to each Spectra Optia Apheresis Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Patients WBC Count Pre-depletion Procedure | 15.9 cells x 10^9/L | Standard Deviation 18.29 |
Other Pre-specified
Procedure Duration
Time frame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Procedure Duration | 144.5 minutes | Standard Deviation 17.81 |
Other Pre-specified
Total Blood Volume (TBV) Processed
The number of times the patient's total blood volume is processed during the apheresis procedure.
Time frame: Post each Spectra Optia Apheresis Procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Total Blood Volume (TBV) Processed | 1.7 Number of TBVs processed | Standard Deviation 0.25 |
Other Pre-specified
Waste Bag Volume
Time frame: Post each Spectra Optia Apheresis Procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Waste Bag Volume | 669.8 mL | Standard Deviation 248.48 |
Other Pre-specified
Whole Blood Processed (mL)
Volume of patients blood processed during the apheresis procedure.
Time frame: Post each Spectra Optia Apheresis Procedure
Population: Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | Whole Blood Processed (mL) | 6652.3 mL | Standard Deviation 856.42 |