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Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectra Optia Apheresis System | Device | Platelet Depletion |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure | (PLTpre - PLTpost) / PLTpre x 100% | on average this will be within 15 minutes after the end of the procedure |
| 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) | on average this will be within 15 minutes after the end of the procedure |
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient's Platelet Count Pre-depletion Procedure | Prior to each Spectra Optia Apheresis 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone platelet depletion via the Spectra Optia System and who were likely to have had blood disorders, such as essential thrombocythemia, a myeloproliferative disease, or reactive (secondary) thrombocytosis.
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| Name | Affiliation | Role |
|---|---|---|
| Raymond P Goodrich, PhD | VP, Scientific and Clinical Affairs; Chief Science Officer-BBT | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark | |||
| University of Pécs |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.Data were collected from 20 PLTD procedures performed in 12 subjects, which constituted the Full and Safety Analysis Sets.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure | (PLTpre - PLTpost) / PLTpre x 100% | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | % change in PLT count in subject blood | on average this will be within 15 minutes after the end of the procedure | procedures | Participants |
|
|
Adverse event (AE) data (including serious adverse events [SAEs]) were collected from the time of the start of the PLTD procedure until discharge from the Apheresis Unit.
Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and coded using the Medical Dictionary for Regulatory Activities (MedDRA®, Version 17.0).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA®, Version 17. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer-BBT | Terumo BCT | (303) 231-4357 | Ray.Goodrich@terumobct.com |
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| ID | Term |
|---|---|
| D013922 | Thrombocytosis |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| Patients WBC Count Pre-depletion Procedure | Prior to each Spectra Optia Apheresis Procedure |
| 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) | Volume of patients blood processed during the apheresis procedure. | Post each Spectra Optia 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 |
| Procedure Duration | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure |
| Waste Bag Volume | Post each Spectra Optia Apheresis Procedure |
| Total Blood Volume (TBV) Processed | The number of times the patient's total blood volume is processed during the apheresis procedure. | Post each Spectra Optia Apheresis Procedure |
| Pécs |
| 7624 |
| Hungary |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Total Blood Volume | Estimated by Nadler's formula for total blood volume of a human based on gender, height, and weight. | Mean | Standard Deviation | Liters |
|
| Diagnosis | Number | pariticpants |
|
| Counts |
|---|
| Participants |
|
| procedures |
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | % of processed platelets | on average this will be within 15 minutes after the end of the procedure | Procedures | Participants |
|
|
|
| Primary | Adverse Events | 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. | Posted | Number | Number of subjects with at least 1 AE | 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 Pre-specified | Patient's Platelet Count Pre-depletion Procedure | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | cells x 10^3/L | Prior to each Spectra Optia Apheresis Procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Patient's Platelet Count Post-depletion Procedure | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | cells x 10^3/L | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Patients WBC Count Pre-depletion Procedure | Posted | Mean | Standard Deviation | cells x 10^9/L | Prior to each Spectra Optia Apheresis Procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Patient's WBC Count Post-depletion Procedure | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | cells x 10^9/L | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Whole Blood Processed (mL) | Volume of patients blood processed during the apheresis procedure. | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | mL | Post each Spectra Optia Apheresis Procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Average Inlet Flow Rate | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | mL/min | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Procedure Duration | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | minutes | Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Waste Bag Volume | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | mL | Post each Spectra Optia Apheresis Procedure | procedures | Participants |
|
|
|
| Other Pre-specified | Total Blood Volume (TBV) Processed | The number of times the patient's total blood volume is processed during the apheresis procedure. | Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites. | Posted | Mean | Standard Deviation | Number of TBVs processed | Post each Spectra Optia Apheresis Procedure | procedures | Participants |
|
|
|
| 0 |
| 12 |
| 6 |
| 12 |
| Hypotension | Vascular disorders | MedDRA®, Version 17. | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA®, Version 17. | Systematic Assessment |
|
| Malaise | General disorders | MedDRA®, Version 17. | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA®, Version 17. | Systematic Assessment |
|
Study Site reserves the right to publish the results of its work on the Study. Study Site and the PI agree to submit copies of any manuscript/abstract proposed for publication to Sponsor at least 30 days in advance of the presentation. Sponsor may require the delay of publication for no longer than 90 days for the purpose of filing patent applications.