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INTERCEPT Treated RBCs for Anemia (ReCePI Trial)

Phase 3
Waitlist Available
Led By Richard J Benjamin, MD
Research Sponsored by Cerus Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 75 days
Awards & highlights

Summary

This trial is testing a special type of blood transfusion for patients having complex heart surgery. The new treatment aims to make blood transfusions safer by reducing infections and complications. The study will evaluate if this new method works effectively.

Who is the study for?
This trial is for patients weighing at least 40 kg, aged 11 or older, undergoing complex cardiac surgery such as multiple valve repairs or coronary artery bypass grafts. They must not be pregnant and agree to use reliable birth control if of child-bearing potential. Excluded are those with certain allergies, autoimmune diseases affecting red blood cells, severe kidney or liver issues, recent transfusions or participation in other clinical trials.
What is being tested?
The study tests the safety and effectiveness of the INTERCEPT Blood System for Red Blood Cells (RBCs) in patients with acute anemia from cardiovascular surgeries. It compares outcomes like renal impairment after receiving INTERCEPT-treated RBCs versus conventional RBC transfusions.
What are the potential side effects?
While specific side effects aren't listed here, generally blood transfusion risks include allergic reactions, fever, iron overload from frequent transfusions over time and rarely infectious disease transmission.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~75 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 75 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients who have received at least one study transfusion with a diagnosis of renal impairment defined as
Treatment emergent antibodies
Secondary study objectives
Adverse Events
HLA allo-antigens
Mortality or the need for RRT
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: INTERCEPT (test)Experimental Treatment1 Intervention
The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician.
Group II: Conventional (Control)Active Control1 Intervention
The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The INTERCEPT Blood System for RBCs works by reducing pathogens and inactivating white blood cells in transfused blood, which helps prevent infections and immune reactions in anemia patients. This is crucial as it ensures safer transfusions, reducing complications and improving patient outcomes. Erythropoiesis-stimulating agents (ESAs) stimulate the bone marrow to produce more red blood cells, addressing anemia caused by insufficient RBC production. Iron supplementation is used to treat iron-deficiency anemia by replenishing iron stores necessary for hemoglobin production. These treatments collectively improve oxygen delivery to tissues, alleviating symptoms and enhancing the quality of life for anemia patients.
The effects of high energy and micronutrient supplementation on iron status in nutritionally at risk infants.

Find a Location

Who is running the clinical trial?

Cerus CorporationLead Sponsor
18 Previous Clinical Trials
4,576 Total Patients Enrolled
3 Trials studying Anemia
881 Patients Enrolled for Anemia
Richard J Benjamin, MDPrincipal InvestigatorCerus Corporation

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT03459287 — Phase 3
Anemia Research Study Groups: INTERCEPT (test), Conventional (Control)
Anemia Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT03459287 — Phase 3
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT03459287 — Phase 3
~43 spots leftby Sep 2025
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