Skip to main content
OpenTrials
Completed

NCT Number: NCT02308787

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

Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thrombocythemia Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disease Myeloproliferative Disorders Thrombocytosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spectra Optia Apheresis System

Device

Platelet Depletion

Primary outcomes

  1. 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%

  2. 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)

  3. 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).

Other outcomes

  1. Patient's Platelet Count Pre-depletion Procedure

    Time frame: Prior to each Spectra Optia Apheresis Procedure

  2. 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

  3. Patients WBC Count Pre-depletion Procedure

    Time frame: Prior to each Spectra Optia Apheresis Procedure

  4. 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

  5. Whole Blood Processed (mL)

    Time frame: Post each Spectra Optia Apheresis Procedure

    Volume of patients blood processed during the apheresis procedure.

  6. 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

  7. Procedure Duration

    Time frame: Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure

  8. Waste Bag Volume

    Time frame: Post each Spectra Optia Apheresis Procedure

  9. 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.

Sponsors and collaborators

Lead sponsor

Terumo BCT

Industry

Registry information

Official study title

Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.

Acronym: PLTD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.