NCT02302365

Brief Summary

This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

November 18, 2014

Results QC Date

November 12, 2015

Last Update Submit

July 2, 2018

Conditions

Leukocytosis

Keywords

white blood cell depletionapheresis

Outcome Measures

Primary Outcomes (3)

  • Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure

    Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%

    immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure

  • Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.

    Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)

    immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure

  • Adverse Events

    Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.

    Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.

Other Outcomes (9)

  • Pre-procedure WBC Count

    Prior to Each Spectra Optia Apheresis Procedure

  • Post-procedure WBC Count

    Following apheresis procedure

  • Patient's Platelet Count Pre-depletion Procedure

    Prior to Each Spectra Optia Apheresis Procedure

  • +6 more other outcomes

Interventions

Spectra Optia® Apheresis SystemDEVICE

White Blood Cell Depletion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have undergone white blood cell depletion via the Spectra Optia Apheresis System which is likely to include patients with severe leukocytosis in acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, or in chronic myelogenous leukemia) or to prevent tumor lysis syndrome.

You may qualify if:

  • Patients having received a minimum of 1 white blood cell depletion procedure via the Spectra Optia Apheresis System

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service Baden-Württemberg-Hessen gGmbH, Johann-Wolfgang-Goethe-University Hospital

Frankfurt am Main, 60528, Germany

Location

Szent Istvan and Szent Laszlo Hospital of Budapest

Budapest, 1097, Hungary

Location

MeSH Terms

Conditions

Leukocytosis

Condition Hierarchy (Ancestors)

Leukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Isobelle Galeon, MD, MPH, MSCS, Medical Monitor Clinical Safety
Organization
Terumo BCT
Isobelle.Galeon@Terumobct.com
+1 303 542-5166

Study Officials

  • Isobelle Galeon, MD, MPH, MSCS

    Medical Monitor, Clinical Safety

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 27, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 3, 2018

Results First Posted

March 3, 2016

Record last verified: 2018-07

Locations

HU(1)BE(1)DE(1)