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

Overview

About this study

The purpose 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gregory Nuttall, M.D.

Closed for enrollment

Contact information:

Midhat Mujic R.R.T., L.R.T.

(507) 293-2612

Mujic.Midhat@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20491465

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