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

Completed

• Conditions: Thrombocytosis; Thrombocythemia; Myeloproliferative Disease

• Registration Number: NCT02308787
• Lead Sponsor: Terumo BCT

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-02-03
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-10
• Last Update Submitted: 2016-05-10
• Results First Posted: 2016-06-15
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure	on average this will be within 15 minutes after the end of the procedure	(PLTpre - PLTpost) / PLTpre x 100%
Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.	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)
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).

Trial Locations

Locations (2)

University of Pécs; 🇭🇺 Pécs, Hungary

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark