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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cerus Corporation
Study ID
NCT03459287
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
11 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INTERCEPT — DEVICE
    Pathogen reduced RBCs
  • Control — DEVICE
    Conventional RBCs

Study Details

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.

Key Dates

Start date
Dec 5, 2018
Status verified
Jun 2025
Primary completion
Dec 4, 2023
Completion
Mar 5, 2024

Study Design

Enrollment
581 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: INTERCEPT (test)
    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.
  • Active Comparator: Conventional (Control)
    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.

Primary Outcome Measure

Percentage of Patients Who Have Received at Least One Study Transfusion With a Diagnosis of Renal Impairment Defined as: [ Time Frame: Within 48±4 hours of the end of surgery ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095-
StanfordStanfordCalifornia94305-
University of Colorado HospitalAuroraColorado80045-
Bridgeport HospitalBridgeportConnecticut06610-
Yale New Haven HospitalNew HavenConnecticut06510-
University of FloridaGainesvilleFlorida32611-
EmoryAtlantaGeorgia30308-
University of KentuckyLexingtonKentucky40356-
University of MichiganAnn ArborMichigan48109-
Henry Ford Health SystemDetroitMichigan48202-
Mayo-RochesterRochesterMinnesota55905-
Duke University Health SystemDurhamNorth Carolina27710-
TemplePhiladelphiaPennsylvania19140-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Rhode Island HospitalProvidenceRhode Island02903-
University of Texas SouthwesternDallasTexas75390-
Houston MethodistHoustonTexas77030-
University of Virginia Health SystemCharlottesvilleVirginia22908-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CAStanford· Stanford, CAUniversity of Colorado Hospital· Aurora, COBridgeport Hospital· Bridgeport, CTYale New Haven Hospital· New Haven, CTUniversity of Florida· Gainesville, FL

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