Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 7/29/22. Questions regarding updates should be directed to the study team contact.