common.study.topics.clinical

Blood

common.study.values.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).

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

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.

participant.views.study.view.additional

participant.views.study.view.scientific-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

common.study.values.clinical-trial-id

NCT04022889

participant.views.study.view.id

aADL3e