A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study

PHASE2TerminatedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Healthy
Interventions
BIOLOGICAL

Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.

Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with INTERCEPT treated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.

BIOLOGICAL

Autologous apheresis Conventional untreated Platelet Components

Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with conventional untreated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.

Trial Locations (2)

45267

Hoxworth Blood Center, Cincinnati

03766

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cerus Corporation

INDUSTRY