What side effects are associated with this type of intervention?

Common treatments for anemia include red blood cell (RBC) transfusions, erythropoiesis-stimulating agents (ESAs), and iron supplementation. RBC transfusions can lead to complications such as alloimmunization, infections, and iron overload. ESAs are associated with an increased risk of thrombosis and hypertension. Iron supplementation, whether oral or intravenous, can cause gastrointestinal disturbances, including constipation and nausea, and in some cases, iron overload. The INTERCEPT Blood System, which involves pathogen reduction and white blood cell inactivation, aims to reduce the risk of transfusion-transmitted infections and immunological reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for anemia, including erythropoiesis-stimulating agents (ESAs) like epoetin alfa and darbepoetin alfa, which stimulate red blood cell production. Additionally, iron supplements such as ferric pyrophosphate citrate (Triferic™) are used to maintain hemoglobin levels in chronic hemodialysis patients. The INTERCEPT Blood System, which focuses on pathogen reduction and white blood cell inactivation, is being studied for its efficacy and safety in reducing complications associated with red blood cell transfusions in complex cardiac surgery patients. This system aims to improve the safety of blood transfusions by inactivating pathogens and white blood cells, potentially reducing the risk of transfusion-related adverse events.

What other types of research exist?

Promising novel alternatives to the INTERCEPT Blood System for anemia patients include the use of recombinant erythropoietin (EPO) to stimulate red blood cell production, gene therapy approaches targeting underlying genetic causes of anemia, and advanced iron chelation therapies to manage iron overload in chronic transfusion patients. Additionally, the development of synthetic or bioengineered red blood cells and the use of hematopoietic stem cell transplantation (HCT) for certain types of anemia are also being explored as potential treatments.

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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 75 days

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Do I qualify?Apply below to find out

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.