Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03459287 | Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients | PHASE3 | COMPLETED | 581 | — | — | Dec 5, 2018 | Mar 5, 2024 | Sep 10, 2025 | 18 | United States |
Any raised serum creatinine (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.
Percentage 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.
Percentage of patients with treatment-emergent antibodies with confirmed specificity to INTERCEPT RBCs by the end of study.
| Arm | Type | Description |
|---|---|---|
| INTERCEPT (test) | EXPERIMENTAL | 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. |
| Conventional (Control) | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| INTERCEPT | DEVICE | Pathogen reduced RBCs |
| Control | DEVICE | Conventional RBCs |
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 ...