NCT01716923

Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia

A Randomized Controlled Double-Blind Phase 3 Study to Assess Characteristics of S 303 Treated RBC Components and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Cerus Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.

Conditions

• Focus:Use of S303 RBCs in Patients With Acute Anemia

Interventions

Type	Name	Description
BIOLOGICAL	S-303 Red Blood Cells (RBCs) - Test
BIOLOGICAL	Conventional, untreated red blood cells (RBCs) - Control

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2012-10-30
• Last updated: 2015-08-26

Locations

2 sites across 1 country: Germany