Trial results for the INTERCEPT Blood System for Red Blood Cells (RBCs), investigating support for acute anemia in complex cardiac surgery patients, were posted on ClinicalTrials.gov on 2025-09-10. The study found similar rates of renal impairment, with 46 participants in the INTERCEPT group and 45 in the conventional RBC group experiencing this outcome.
Background
Anemia is a common concern in patients undergoing complex cardiac surgery, often requiring red blood cell transfusions. The INTERCEPT Blood System for RBCs is designed to enhance the safety of transfused blood components. This Phase 3 study aimed to evaluate the efficacy and safety of RBC transfusions treated with the INTERCEPT Blood System compared to conventional RBCs, specifically focusing on the clinical outcome of renal impairment following transfusion in this patient population.
Trial design
This Phase 3 study, titled "Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients," enrolled 581 participants. The trial focused on patients with Anemia. The objective was to evaluate the efficacy and safety of RBC transfusion for the support of acute anemia in cardiovascular surgery patients. The primary endpoint was based on the clinical outcome of renal impairment following transfusion of red blood cells treated with the INTERCEPT Blood System for Red Blood Cells (IBS) compared to patients transfused with conventional RBCs.
Key results
The study reported on several key measurements:
- Percentage of Patients Who Have Received at Least One Study Transfusion With a Diagnosis of Renal Impairment Defined as:
- In the INTERCEPT (Test) group, 46 participants were diagnosed with renal impairment.
- In the Conventional (Control) group, 45 participants were diagnosed with renal impairment.
- Percentage of Patients With Related Adverse Events:
- In the INTERCEPT (Test) group, 4 participants experienced related adverse events.
- In the Conventional (Control) group, 1 participant experienced related adverse events.
- Percentage of Patients With Treatment Emergent Antibodies:
- In the INTERCEPT (Test) group, 5 participants developed treatment emergent antibodies.
- In the Conventional (Control) group, 0 participants developed treatment emergent antibodies.
- Percentage of Patients With a Diagnosis of Stage I, II or III Acute Kidney Injury:
- For one measurement, the Test group had 8 participants and the Control group had 9 participants.
- For another measurement, the Test group had 15 participants and the Control group had 7 participants.
- For a third measurement, the Test group had 36 participants and the Control group had 39 participants.
What this means
The posted results indicate that the INTERCEPT Blood System for Red Blood Cells demonstrated similar rates of renal impairment compared to conventional RBCs in complex cardiac surgery patients, with 46 participants in the INTERCEPT group and 45 in the conventional group experiencing this outcome. However, the INTERCEPT group reported a higher number of related adverse events (4 participants vs. 1) and treatment emergent antibodies (5 participants vs. 0) compared to the conventional RBC group. The data for acute kidney injury stages showed varied results across different measurements. These findings suggest that while the INTERCEPT system may not significantly alter the risk of renal impairment in this context, it was associated with a higher incidence of certain safety-related outcomes in this study.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03459287, titled "Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients", were posted on 2025-09-10 on clinicaltrials.gov.