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INTERCEPT Safety Evaluation in Anemic Patients

NCT03486054 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-12-13

No results posted yet for this study

Summary

The pathogen reduction (PR) system for Whole Blood (WB) using Amustaline (S-303) and Glutathione (GSH) has a potential to decrease transfusion-transmitted infection. There is scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses and parasites that could be present in blood collected from asymptomatic infected donors are inactivated in the treated whole blood and therefore reduce the risk of transfusion-transmitted infections. The aim of the study is to gather data to support the safety of whole blood products that underwent treatment with amustaline and glutathione and data to support a larger sufficiently powered efficacy study. This study will evaluate the safety of the system for whole blood in adult patients with anemia.

This study is designed as a randomized, controlled, open-label study. The aim is to explore the safety of the whole blood product treated with a PR system using amustaline and glutathione.

The study will enroll 20 patients with anemia. 20 patients will be randomized either to treated WB (Test) or Standard of Care, either Red Blood Cells or Whole Blood (Control).

Conditions

Interventions

DEVICE

INTERCEPT

The pathogen reduction process begins with a unit of whole blood collected according to local standards and procedures at the blood center. The blood unit is treated with amustaline and glutathione (INTERCEPT blood system for whole blood) according to manufacturer's instructions. The INTERCEPT blood system is performed on a single unit of not leuco-reduced whole blood treated with amustaline and glutathione in CPD

DEVICE

Standard of Care

The control article is Standard of Care, either RBC or whole blood collected by the Centre National de Transfusion Sanguine (CNTS), processed according to the local procedure and in compliance with quality criteria defined by the manufacture regarding the volume, hemoglobin content, hematocrit, storage temperature, age of blood and storage in the predefined anticoagulant solution.

Sponsors & Collaborators

  • Cerus Corporation

    collaborator INDUSTRY

  • Swiss Transfusion SRC

    lead OTHER

Principal Investigators

  • Soraya Amar, MD · Transfusion SRC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-03-31
Completion
2020-06-30

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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 NCT03486054 on ClinicalTrials.gov