Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients

NCT03459287 | Completed Phase 3 Results DMC FDA Device

• 1 other identifier: CLI 00125
• Study Type: interventional
• Target: 581
• Locations: 1 country
• Sites: 18

Brief Summary

The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.

Conditions

Anemia

Keywords

INTERCEPT; Red Blood Cells; RBC; Pathogen Inactivation; Cerus; Pathogen Reduction; Cardiovascular surgery

Outcome Measures

Primary Outcomes (3)

• Percentage of Patients Who Have Received at Least One Study Transfusion With a Diagnosis of Renal Impairment Defined as:

  Any raised serum creatinine (sCr) level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL (or 26.5 µmol/L) from the pre-surgery baseline within 48±4 hours of the end of surgery.

  Within 48±4 hours of the end of surgery

• Percentage of Patients With Related Adverse Events

  Percentage of patients with any treatment-emergent adverse events (TEAEs) possibly, probably or definitely related to study RBC transfusion through 28 days after the last study transfusion.

  From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

• Percentage of Patients With Treatment Emergent Antibodies

  Percentage of patients with treatment-emergent antibodies with confirmed specificity to INTERCEPT RBCs by the end of study.

  From the start of the first study transfusion to 75 days after the last study transfusion (between 76-82 days depending on the day of the last study transfusion).

Secondary Outcomes (2)

• Percentage of Patients With a Diagnosis of Stage I, II or III Acute Kidney Injury

  7 days

• Mortality or the Need for RRT

  30 days

Other Outcomes (5)

• Number of Participants With Treatment-emergent (TE) Immunization to RBC Alloantigens

  From the start of the first study transfusion to 28 after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

• Number of Participants With Transfusion Reactions (TR)

  From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

• Number of Participants With Serious Adverse Events (SAEs)

  From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).

Study Arms (2)

INTERCEPT (test)

EXPERIMENTAL

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.

Device: INTERCEPT

Conventional (Control)

ACTIVE COMPARATOR

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.

Device: Control

Interventions

INTERCEPT DEVICE

Pathogen reduced RBCs

INTERCEPT (test)

Control DEVICE

Conventional RBCs

Conventional (Control)

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 11 years of age
• Weight ≥ 40 kg
• Scheduled complex cardiac surgery or thoracic aorta surgery. The procedure may be performed either on or off cardiopulmonary bypass machine (CBP or "pump"). For the purposes of this protocol "Repeat procedure" means that the subject had a previous cardiac surgery. Procedures that qualify as complex cardiac surgery include but are not limited to, the following:
• Single Vessel Coronary Artery Bypass Graft, first or repeat procedure
• Multiple Coronary Artery Bypass Grafts, first or repeat procedure
• Single Valve Repair or Replacement, first or repeat procedure
• Multiple Valve Repair or Replacement, first or repeat procedure
• Surgery involving both Coronary Artery Bypass Graft(s) and Valve Repair(s), first or repeat procedure
• One or more of the following procedures, with or without Coronary Bypass Graft(s):
• left ventricular aneurysm repair
• ventricular and/or atrial septal defect repairs
• Batista procedure (surgical ventricular remodeling)
• surgical ventricular restoration
• congenital cardiac defect repair
• aortic procedures

You may not qualify if:

• Confirmed positive baseline serum/plasma antibody specific to INTERCEPT RBCs (S-303 specific antibody) screening panel prior to randomization.
• Pregnant or breast feeding
• Refusal of blood products or other inability to comply with the protocol in the opinion of the Investigator or the treating physician
• Treatment with any medication that is known to adversely affect RBC viability, such as, but not limited to dapsone, levodopa, methyldopa, nitrofurantoin, and its derivatives, phenazopyridine and quinidine.
• Planned cardiac transplantation
• Active autoimmune hemolytic anemia
• Left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO) support pre operatively or planned need post-operatively
• Cardiogenic shock requiring pre-operative placement of an intra-aortic balloon pump (IABP) (NOTE: IABP done for unstable angina or prophylactically for low ejection fraction is not excluded).
• Planned use of autologous or directed donations.
• RBC transfusion during current hospitalization prior to enrollment and randomization (within 7 days).
• Patients with a current diagnosis of either chronic kidney disease or acute kidney injury and with sCr ≥1.8 mg/dL at screening and patients requiring RRT. (NOTE: If sCr at screening is \<1.8 mg/dL, a patient with a diagnosis of chronic or acute kidney injury alone is not excluded).
• Patients with a current diagnosis of either chronic or acute hepatic insufficiency and with a total serum bilirubin ≥ 2.0 mg/dL (≥34.2 µmol/L). (NOTE: If total serum bilirubin at screening is \<2.0 mg/dL, a patient with a diagnosis of chronic or acute hepatic failure alone is not excluded).
• Pre-existing antibody(ies) to RBC antigens that may make the provision of compatible study RBC components difficult.
• History of TRs requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.
• Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.

Sponsors & Collaborators

• Cerus Corporation: lead

Study Sites (18)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Emory

Atlanta, Georgia, 30308, United States

Location

University of Kentucky

Lexington, Kentucky, 40356, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo-Rochester

Rochester, Minnesota, 55905, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Temple

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (2)

• Sekela ME, Snyder EL, Welsby IJ, Toyoda Y, Alsammak M, Sodha NR, Beaver TM, Pelletier JPR, Gorham JD, McNeil JS, Sniecinski RM, Pearl RG, Nuttall GA, Sarode R, Reece TB, Benjamin RJ; and the ReCePI Study Collaborators. Transfusion of Amustaline/Glutathione Pathogen-reduced Red Blood Cells in Cardiac Surgery: A Randomized Phase 3 Clinical Trial. Anesthesiology. 2025 Nov 1;143(5):1196-1210. doi: 10.1097/ALN.0000000000005716. Epub 2025 Aug 12.

  PMID: 41085306 DERIVED

• Karim C, Panigrahi A, Pearl RG, Sodha NR, Beaver TM, Pelletier JPR, Nuttall GA, Reece TB, Erickson A, Hedrick T, Liu K, Bentow S, Corash L, Mufti N, Varrone J, Benjamin RJ. Characterizing the antibody response to amustaline/glutathione pathogen-reduced red blood cells. Transfusion. 2025 Feb;65(2):344-353. doi: 10.1111/trf.18117. Epub 2024 Dec 25.

  PMID: 39719927 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Richard Benjamin, M.D., Ph.D.
• Organization: Cerus Corp

rbenjamin@cerus.com

925 288 6000

Study Officials

• Richard J Benjamin, MD

  Cerus Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: December 5, 2018
• Primary Completion: December 4, 2023
• Study Completion: March 5, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (18)