Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263809
Status:
COMPLETED
Last Update Posted:
2009-10-07
First Post:
2005-12-07
Brief Title:
Safety and Performance of MIRASOL PRT Treated Platelet Transfusion Products
Sponsor:
Terumo BCTbio
Organization:
Terumo BCTbio
Study Overview
Official Title:
Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL Pathogen Reduction Technology A Study in Human Thrombocytopenic Subjects
Status:
COMPLETED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events SAE The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device test product versus untreated reference product
Detailed Description:
The objective of the study is to determine if the MIRASOL Pathogen Reduction Technology PRT System for Platelets device performs safely and maintains adequate platelet performance in a clinical setting This will be achieved by comparing the platelet corrected count increment measured 1 hour post transfusion and the incidence of serious adverse events in response to the infusion of platelet concentrates treated with the device test product versus untreated reference product in thrombocytopenic subjects requiring platelet transfusions The performance safety and tolerability profile of the device will be further assessed by monitoring and comparing the incidence of discontinuations due to adverse events in relation to platelet transfusion up to 4 weeks after transfusion including the incidence of transfusion associated infections and the number and time between transfusions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None