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

NCT02308787 | Completed Results

• 1 other identifier: CTS-5052
• Study Type: observational
• Target: 12
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Thrombocythemia; Myeloproliferative Disease; Thrombocytosis

Keywords

platelet depletion; apheresis

Outcome Measures

Primary Outcomes (3)

• Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis 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.

  (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

  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 (9)

• Patient's Platelet Count Pre-depletion Procedure

  Prior to each Spectra Optia Apheresis Procedure

• Patient's Platelet Count Post-depletion 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

  Prior to each Spectra Optia Apheresis Procedure

Interventions

Spectra Optia Apheresis System DEVICE

Platelet Depletion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (2)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

University of Pécs

Pécs, 7624, Hungary

Location

MeSH Terms

Conditions

Thrombocytosis; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Results Point of Contact

• Title: Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer-BBT
• Organization: Terumo BCT

Ray.Goodrich@terumobct.com

(303) 231-4357

Study Officials

• Raymond P Goodrich, PhD

  VP, Scientific and Clinical Affairs; Chief Science Officer-BBT

  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: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 15, 2016
• Results First Posted: June 15, 2016

Record last verified: 2016-05

Locations

HU (1); DK (1)