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

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ClinicalTrials.gov Identifier: NCT03459287
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Cerus Corporation

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.

Condition or disease Intervention/treatment Phase
Anemia Device: INTERCEPT Device: Control Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 30, 2023

Arm Intervention/treatment
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.
Device: INTERCEPT
Pathogen reduced RBCs

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.
Device: Control
Conventional RBCs




Primary Outcome Measures :
  1. Proportion of patients who have received at least one study transfusion with a diagnosis of renal impairment defined as: [ Time Frame: 48 hours ]
    Any raised 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.

  2. Adverse Events [ Time Frame: 28 Days ]
    Proportion 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.

  3. Treatment emergent antibodies [ Time Frame: 75 days ]
    • Proportion of patients with treatment-emergent antibodies with confirmed specificity to INTERCEPT RBCs by the end of study (i.e., 75±15 days after the last study transfusion).


Secondary Outcome Measures :
  1. Proportion of patients with a diagnosis of stage I, II or III Acute Kidney Injury [ Time Frame: 28 days ]
    The proportion of patients with a diagnosis of stage I, II or III Acute Kidney Injury (KDIGO 2012) based on changes in sCr levels from pre-surgery baseline and the need for renal replacement therapy (RRT) post surgery.

  2. Mortality or the need for RRT [ Time Frame: 30 days ]
    Mortality or the need for RRT by 30 days post surgery

  3. Adverse Events [ Time Frame: 28 days ]
    Treatment-emergent AEs through 28 days after the last study transfusion.

  4. SAEs [ Time Frame: 28 days ]
    Treatment-emergent SAEs through 28 days after the last study transfusion.

  5. Transfusion reactions [ Time Frame: 28 days ]
    Transfusion reactions (as defined by the CDC National Healthcare Safety Network [NHSN] Hemovigilance Module protocol) through 28 days after last study transfusion.

  6. RBC allo-antigens [ Time Frame: 28 days ]
    Treatment-emergent immunization to RBC allo-antigens through 28 +/- 3 days after the last study transfusion

  7. HLA allo-antigens [ Time Frame: 28 days ]
    Treatment-emergent immunization to HLA allo-antigens through 28 +/-3 days after the last study transfusion



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 11 years of age
  2. Weight ≥ 40 kg
  3. 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
      • other cardiac surgery or thoracic aorta surgery types with a high probability of bleeding
  4. TRUST probability score (Alghamdi, Davis et al. 2006) ≥ 3, or currently on a regimen of aspirin (any dose), clopidogrel (or analogs) and/or GPIIb/IIIa inhibitors or at a high probability for need of a transfusion during or after surgery at the discretion of the Investigator
  5. Female subjects of child-bearing potential must meet the 2 criteria below at screening:

    • Negative serum or urine pregnancy test
    • Use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner
  6. Signed and dated informed consent/assent form

Exclusion Criteria:

  1. Confirmed positive baseline serum/plasma antibody specific to INTERCEPT RBCs (S-303 specific antibody) screening panel prior to randomization.
  2. Pregnant or breast feeding
  3. Refusal of blood products or other inability to comply with the protocol in the opinion of the Investigator or the treating physician
  4. 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.
  5. Planned cardiac transplantation
  6. Active autoimmune hemolytic anemia
  7. Left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO) support pre operatively or planned need post-operatively
  8. 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).
  9. Planned use of autologous or directed donations.
  10. RBC transfusion during current hospitalization prior to enrollment and randomization (within 7 days).
  11. Participation in an interventional clinical study concurrently or within the previous 28 days. This includes investigational blood products, pharmacologic agents, imaging materials (including dyes), surgical techniques, or devices. Observational studies of FDA cleared or approved products or nutrition, psychology, or socioeconomic issues are not grounds for exclusion
  12. 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).
  13. 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).
  14. Pre-existing antibody(ies) to RBC antigens that may make the provision of compatible study RBC components difficult.
  15. History of TRs requiring washed RBCs, volume reduced RBC, or RBCs with additive solution removed.
  16. Patients with documented IgA deficiency or a history of severe allergic reactions to blood products.
  17. Patients who require gamma-irradiated RBC blood components.
  18. Positive DAT as defined below:

A polyspecific DAT reaction strength > 2+, or

A polyspecific DAT (any strength) in conjunction with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459287


Contacts
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Contact: Alison Coombs 925-288-6203 acoombs@cerus.com
Contact: Chris Marston 949-275-8702 cmarston@cerus.com

Locations
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United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Peyman Benharash, Dr         
Stanford Recruiting
Stanford, California, United States, 94305
Contact: Ronald Pearl, Dr         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Thomas Reece, Dr         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Edward Snyder, Dr    203-688-2441      
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Thomas Beaver, Dr         
United States, Georgia
Emory Recruiting
Atlanta, Georgia, United States, 30308
Contact: Roman Sniecinski, Dr         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40356
Contact: Michael Sekela, Dr    859-323-6494    mese223@uky.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Robertson Davenport, Dr         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Ileana Lopez-Plaza, Dr         
United States, Minnesota
Mayo-Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gregory Nuttall, Dr         
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Ian Welsby, Dr    919-668-5111      
United States, Pennsylvania
Temple Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Yoshiya Toyoda, Dr         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Alesia Kaplan, Dr    412-209-7238      
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Neel Sodha, Dr    401-274-7546      
United States, Texas
Houston Methodist Terminated
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: James Gorham, Dr         
Sponsors and Collaborators
Cerus Corporation
Investigators
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Principal Investigator: Richard J Benjamin, MD Cerus Corporation
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Responsible Party: Cerus Corporation
ClinicalTrials.gov Identifier: NCT03459287    
Other Study ID Numbers: CLI 00125
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Cerus Corporation:
INTERCEPT
Red Blood Cells
RBC
Pathogen Inactivation
Cerus
Pathogen Reduction
Cardiovascular surgery