Clinical Trial

Blood

Study Description

In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days

The objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain sufficient viability for therapeutic transfusion efficacy. The post infusion recovery and survival of radiolabeled 7, 6 or 5- day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to their "fresh" radiolabeled platelet (Control) according to FDA guidance for platelet testing (FDA 1999).

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Device - INTERCEPT Treated Platelets

Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7, 6 or 5 days at 20°C-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets will be simultaneously administered intravenously into the subject.

Additional Information

Official Study Title

A Randomized, Multi-center, Multi-Stage, Controlled, In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days

Clinical Trial ID

NCT04022889

ParticipAid ID

aADL3e