ThrombocythemiaPLTDNCT02308787
Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions
An observational study of Thrombocythemia and Myeloproliferative Disease, run by Terumo BCT at 2 sites in 2 countries.
Trial summary
Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombocythemia, Myeloproliferative Disease, Thrombocytosis
- What is being tested?
- Spectra Optia Apheresis System
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2014to May 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
Read the 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.
- Conditions
- Thrombocythemia, Myeloproliferative Disease, Thrombocytosis
- Being tested
- Spectra Optia Apheresis System
- Keywords
- platelet depletion, apheresis
- Medical subject headings
- Thrombocytosis, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectra Optia Apheresis SystemDevice
Platelet Depletion
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
(PLTpre - PLTpost) / PLTpre x 100%
Measured: 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)
Measured: on average this will be within 15 minutes after the end of the procedure
Adverse Events
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ThrombocythemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond P Goodrich, PhD, Study director, VP, Scientific and Clinical Affairs; Chief Science Officer-BBT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308787
- Sponsor's protocol ID
- CTS-5052
- Acronym
- PLTD
- Status last verified
- May 2016
- First submitted
- 18 Nov 2014
- Last updated
- 15 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
- ClinicalTrials.gov ID
- NCT02308787
- Acronym / sponsor ID
- PLTD / CTS-5052
- Conditions
- Thrombocythemia, Myeloproliferative Disease, Thrombocytosis
- Keywords
- platelet depletion, apheresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Terumo BCTIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 15 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectra Optia Apheresis SystemPlatelet Depletion | Device | – |
Primary outcome
Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
Time frame: 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.
Time frame: 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
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond P Goodrich, PhD study director
VP, Scientific and Clinical Affairs; Chief Science Officer-BBT
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocythemia and Myeloproliferative Disease, run by Terumo BCT at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure (time frame: on average this will be within 15 minutes after the end of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.