NCT01711346

A Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells

A Randomized, Controlled, Single-Blind, 2-Period Crossover Study to Assess the Recovery and Lifespan of Radiolabeled Autologous S303 Treated Red Blood Cells

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Cerus Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the post-infusion viability of S-303 Red Blood Cells (RBC) by measuring the 24 hour post-infusion recovery and lifespan of autologous RBCs prepared with the S-303 Treatment System for RBC after storage for 35 days in comparison to conventional untreated RBCs stored for 35 days.

Conditions

• Focus: Assess Post Infusion Viability of S303 RBCs

Interventions

Type	Name	Description
BIOLOGICAL	S303 Red Blood Cells (RBCs)	Each subject will receive one intravenous infusion of autologous radiolabeled S303 Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.
BIOLOGICAL	Conventional, untreated Red Blood Cells (RBCs)	Each subject will receive one intravenous infusion of autologous radiolabeled Conventional, untreated Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-07-01
• Completion: 2014-11-01
• First posted: 2012-10-22
• Last updated: 2015-12-16

Locations

2 sites across 1 country: United States