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
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|Condition or disease||Intervention/treatment||Phase|
|Anemia||Device: INTERCEPT Device: Control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel group|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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.
- 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.
- 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).
- 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.
- Mortality or the need for RRT [ Time Frame: 30 days ]Mortality or the need for RRT by 30 days post surgery
- Adverse Events [ Time Frame: 28 days ]Treatment-emergent AEs through 28 days after the last study transfusion.
- SAEs [ Time Frame: 28 days ]Treatment-emergent SAEs through 28 days after the last study transfusion.
- 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.
- RBC allo-antigens [ Time Frame: 28 days ]Treatment-emergent immunization to RBC allo-antigens through 28 +/- 3 days after the last study transfusion
- HLA allo-antigens [ Time Frame: 28 days ]Treatment-emergent immunization to HLA allo-antigens through 28 +/-3 days after the last study transfusion
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||11 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- other cardiac surgery or thoracic aorta surgery types with a high probability of bleeding
- 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
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
- Signed and dated informed consent/assent form
- 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).
- 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
- 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.
- Patients who require gamma-irradiated RBC blood components.
- 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
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
|Contact: Alison Coombsemail@example.com|
|Contact: Chris Marstonfirstname.lastname@example.org|
|United States, California|
|University of California Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Peyman Benharash, Dr|
|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|
|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 email@example.com|
|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|
|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|
|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, Texas, United States, 77030|
|United States, Virginia|
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: James Gorham, Dr|
|Principal Investigator:||Richard J Benjamin, MD||Cerus Corporation|
|Responsible Party:||Cerus Corporation|
|Other Study ID Numbers:||
|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|
|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|
Red Blood Cells