NCT00263809

Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

Evaluation of the Safety and Performance of Platelet Transfusion Products Treated With MIRASOL® Pathogen Reduction Technology. A Study in Human Thrombocytopenic Subjects.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Terumo BCTbio · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DEVICE	Pathogen Reduction Technology

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2005-12-09
• Last updated: 2009-10-07

Locations

10 sites across 1 country: France