Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac… (NCT03459287) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
United States581 participantsStarted 2018-12-05
Plain-language 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.
Who can participate
Age range11 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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:
✓. Signed and dated informed consent/assent form
Exclusion criteria
✕. 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.
What they're measuring
1
Percentage of Patients Who Have Received at Least One Study Transfusion With a Diagnosis of Renal Impairment Defined as:
Timeframe: Within 48±4 hours of the end of surgery
2
Percentage of Patients With Related Adverse Events
Timeframe: From the start of the first study transfusion to 28 days after the last study transfusion (between 29 and 35 days depending on the day of the last study transfusion).
3
Percentage of Patients With Treatment Emergent Antibodies
Timeframe: From the start of the first study transfusion to 75 days after the last study transfusion (between 76-82 days depending on the day of the last study transfusion).
✕. 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).