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Pathogen Reduction System

INTERCEPT Blood System for Blood Transfusion Safety (RedeS Trial)

Phase 3
Recruiting
Research Sponsored by Cerus Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- A diagnosis of a bone marrow failure syndrome requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle cell anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.)
For 28-day +6-month extension study in SCD patients requiring regular repeated RCE:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes - 24 hours post transfusion
Awards & highlights

RedeS Trial Summary

This trial is designed to study the safety and efficacy of the INTERCEPT Blood System for pathogen reduction of red blood cells in comparison to conventional methods. If successful, the system may be made available in areas where transfusion-transmissible infections are common.

Who is the study for?
This trial is for people aged 4 and older who need regular blood transfusions due to chronic anemia from conditions like sickle cell, thalassemia, or after chemotherapy. They must not be pregnant, agree to birth control if applicable, and can't have had a recent transfusion or certain allergies.Check my eligibility
What is being tested?
The study tests the INTERCEPT Blood System for treating Red Blood Cells (RBCs) against conventional methods in patients needing RBC support. It aims to see if this system is safe and works well in areas at risk of Zika virus through blood transfusion.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions related to the pathogen reduction treatment process compared with standard RBC transfusions. These could involve immune responses or other complications from altered blood components.

RedeS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need regular blood transfusions due to a long-term anemia condition.
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I am part of a study for sickle cell disease needing regular blood exchanges.
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I have been in a regular blood transfusion program for at least 3 months.
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I have been diagnosed with SCD through a specific blood test.
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I am a woman who can become pregnant.
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I need regular blood transfusions due to a long-term anemia condition.
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I need or will likely need a blood transfusion.
Select...
I am 4 years old or older.

RedeS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes - 24 hours post transfusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes - 24 hours post transfusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adjusted hemoglobin increment
Treatment emergent antibodies
Secondary outcome measures
Hemoglobin
Adverse Events
Adverse Events of Special Interest (AESI)
+5 more

RedeS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: INTERCEPT (Test)Experimental Treatment1 Intervention
Red blood cell components treated with the INTERCEPT Blood System for Red Blood Cells ordered and administered to study patients by their treating physicians according to the local standards of care
Group II: Conventional (Control)Active Control1 Intervention
Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care

Find a Location

Who is running the clinical trial?

Cerus CorporationLead Sponsor
18 Previous Clinical Trials
4,068 Total Patients Enrolled
3 Trials studying Anemia
373 Patients Enrolled for Anemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me if this research study is still enrolling individuals?

"From the information available on clinicaltrials.gov, it seems that this particular trial is still looking for volunteers. The original posting date was 5/11/2017, with the most recent edit on 3/2/2022."

Answered by AI

How many people total will be participating in this research?

"In order to complete this study, 800 willing and eligible patients are needed. To find patients, the research team is looking at multiple sites including Grady Health System in Atlanta, Georgia and Virginia Commonwealth University in Richmond, Virginia."

Answered by AI

Are there any other sites in Canada conducting this clinical trial?

"There are 4 sites currently running this trial, with locations in Atlanta, Richmond, and Dallas, as well as 4 other locations. To minimize strain, patients should choose a location closest to them."

Answered by AI

What are researchers looking to discover through this clinical trial?

"The primary outcome that will be observed in patients within 15 minutes to 24 hours post transfusion is the development of treatment emergent antibodies. Additionally, the study will measure secondary outcomes including HbA clearance, RBC allo-antigens, and transfusion reactions related to study RBCs."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
UT Southwestern Medical Center
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I interested in learning more about anemia.
PatientReceived 2+ prior treatments
~150 spots leftby Oct 2025