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

NCT01716923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2015-08-26

No results posted yet for this study

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

BIOLOGICAL

S-303 Red Blood Cells (RBCs) - Test

BIOLOGICAL

Conventional, untreated red blood cells (RBCs) - Control

Sponsors & Collaborators

  • Cerus Corporation

    lead INDUSTRY

Principal Investigators

  • Arndt H Kiessling, MD · Klinikum der J.-W.-G.-Universität Frankfurt

  • Katharina Madlener, Dr · Kerckhoff-Klinic GmbH

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-07-31
Completion
2014-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716923 on ClinicalTrials.gov