Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thrombocythemia
- Sponsor
- Terumo BCT
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
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%
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)
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).