Clinical trial NCT02308787: Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions
Official title: Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocythemia
Myeloproliferative Disease
Thrombocytosis
Keywords: platelet depletion
apheresis
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
timeFrame: on average this will be within 15 minutes after the end of the procedure
measure: Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.
timeFrame: on average this will be within 15 minutes after the end of the procedure
measure: Adverse Events
timeFrame: 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).
Secondary outcomes:
Other outcomes:
measure: Patient's Platelet Count Pre-depletion Procedure
timeFrame: Prior to each Spectra Optia Apheresis Procedure
measure: Patient's Platelet Count Post-depletion Procedure
timeFrame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
measure: Patients WBC Count Pre-depletion Procedure
timeFrame: Prior to each Spectra Optia Apheresis Procedure
measure: Patient's WBC Count Post-depletion Procedure
timeFrame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
measure: Whole Blood Processed (mL)
timeFrame: Post each Spectra Optia Apheresis Procedure
measure: Average Inlet Flow Rate
timeFrame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
measure: Procedure Duration
timeFrame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
measure: Waste Bag Volume
timeFrame: Post each Spectra Optia Apheresis Procedure
measure: Total Blood Volume (TBV) Processed
timeFrame: Post each Spectra Optia Apheresis Procedure
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Pécs
country: Hungary
facility: University of Pécs
Study officials:
affiliation: VP, Scientific and Clinical Affairs; Chief Science Officer-BBT
name: Raymond P Goodrich, PhD
role: STUDY_DIRECTOR
References: