An observational study in Thrombocythemia, Myeloproliferative Disease and Thrombocytosis, sponsored by Terumo BCT. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2016-06-15.
Sponsored by Terumo BCT (part of Terumo Corporation) · Observational
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.
160 studies on the registry are indexed under Thrombocytosis; 23 are open to participants now.
This study's enrollment of 12 is below the median of 198 across 34 observational studies indexed under Thrombocytosis.
Browse Thrombocytosis studies →Terumo BCT is the lead sponsor of 14 studies on the registry; none are open to participants now.
First submitted after Terumo BCT became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Platelet Depletion
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
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
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).
Patient's Platelet Count Pre-depletion Procedure
Time frame: Prior to each Spectra Optia Apheresis Procedure
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
Patients WBC Count Pre-depletion Procedure
Time frame: Prior to each Spectra Optia Apheresis Procedure
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
Whole Blood Processed (mL)
Volume of patients blood processed during the apheresis procedure.
Time frame: Post each Spectra Optia Apheresis Procedure
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
Procedure Duration
Time frame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
Waste Bag Volume
Time frame: 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.
Time frame: Post each Spectra Optia Apheresis Procedure
| Milestone | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
(PLTpre - PLTpost) / PLTpre x 100%
| % change in PLT count in subject blood | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure | -58.2 ± 12.0 |
(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)
| % of processed platelets | 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 ± 18.3 |
| Number of subjects with at least 1 AE | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Adverse Events | 6 |
| cells x 10^3/L | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Patient's Platelet Count Pre-depletion Procedure | 1740.7 ± 744.95 |
| cells x 10^3/L | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Patient's Platelet Count Post-depletion Procedure | 717.2 ± 336 |
| cells x 10^9/L | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Patients WBC Count Pre-depletion Procedure | 15.9 ± 18.29 |
| cells x 10^9/L | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Patient's WBC Count Post-depletion Procedure | 8.4 ± 6.66 |
Volume of patients blood processed during the apheresis procedure.
| mL | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Whole Blood Processed (mL) | 6652.3 ± 856.42 |
| mL/min | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Average Inlet Flow Rate | 46.7 ± 8.45 |
| minutes | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Procedure Duration | 144.5 ± 17.81 |
| mL | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Waste Bag Volume | 669.8 ± 248.48 |
The number of times the patient's total blood volume is processed during the apheresis procedure.
| Number of TBVs processed | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Total Blood Volume (TBV) Processed | 1.7 ± 0.25 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Who Received a Minimum of 1 PLTD Procedure u | — | 0/12 (0%) | 6/12 (50%) |
| Event | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| AnemiaBlood and lymphatic system disorders | 3/12 |
| HypotensionVascular disorders | 3/12 |
| DizzinessNervous system disorders | 1/12 |
| MalaiseGeneral disorders | 1/12 |
| White blood cell count decreasedInvestigations | 1/12 |
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.
| Age, Customized(years) | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Age (years) | 64.3 ± 13 |
| Sex: Female, Male(Participants) | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Female | 8 |
| Male | 4 |
| Region of Enrollment(participants) | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Denmark | 3 |
| Hungary | 9 |
| Weight(kg) | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Mean | 63.6 ± 13.4 |
| Height(cm) | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Mean | 163.9 ± 9.2 |
| Total Blood Volume(Liters) | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Mean | 4.0 ± 0.7 |
| Diagnosis(pariticpants) | Subjects Who Received a Minimum of 1 PLTD Procedure u |
|---|---|
| Essential thrombocythaemia | 9 |
| Chronic myeloid leukaemia | 1 |
| Myelodysplastic/myeloproliferative neoplasm | 1 |
| Polycythaemia vera | 1 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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