Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
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.
- Age ≥ 11 years of age
- Weight ≥ 40 kg
- Scheduled complex cardiac surgery with planned use of median sternotomy. 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 with median sternotomy. Procedures that qualify as complex cardiac
surgery include but are not limited to, the following:
- Single Vessel Coronary Artery Bypass Graft, repeat procedure
- Multiple Coronary Artery Bypass Grafts, first or repeat procedure
- Single Valve Repair or Replacement, 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
- left ventricular aneurysm repair,
- ventricular and/or atrial septal defect repairs,
- Batista procedure (surgical ventricular remodeling),
- surgical ventricular restoration,
- congenital defect repair, and
- aortic root procedures
- 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:
- 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 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 surgery is minimally invasive
- 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 14 days).
- Participation in any one of the following types of clinical studies either concurrently or within the previous 28 days: investigational blood products, pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices. Studies of 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 transfusion reactions 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.