Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions (PLTD)

May 10, 2016 updated by: Terumo BCT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
  • Hungary
      • Pécs, Hungary, 7624
        • University of Pecs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%
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.
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)
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's Platelet Count Pre-depletion Procedure
Time Frame: Prior to each Spectra Optia Apheresis Procedure
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
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
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
Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure
Whole Blood Processed (mL)
Time Frame: Post each Spectra Optia Apheresis Procedure
Volume of patients blood processed during the apheresis procedure.
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
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
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
Post each Spectra Optia Apheresis Procedure
Total Blood Volume (TBV) Processed
Time Frame: Post each Spectra Optia Apheresis Procedure
The number of times the patient's total blood volume is processed during the apheresis procedure.
Post each Spectra Optia Apheresis Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terumo BCT

Investigators

  • Study Director: Raymond P Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer-BBT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTS-5052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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