Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SOLX · 1 trial · 1 indication
The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.
The level of residual white blood cells in whole blood filtered after either \<8 hours (AS-3) or 20-24hours (SOLX) of room temperature storage or cold storage for 72 hours.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Room Temperature Storage/Filtration | OTHER | SOLX (Investigational Product) and AS-3 (Control) |
| Arm 2 : Cold storage | OTHER | SOLX (Investigational Product) and AS-3 (Control) |
| Name | Type | Description |
|---|---|---|
| SOLX (Investigational) | DRUG | SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit. |
| AS-3 (Control) | DRUG | AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit |
Inclusion Criteria: * Age - Study donor must be ≥ 18 years of age * Weight - Study donor must be ≥ 110 pounds * Temperature - Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral) * Hemoglobin - Study donor's hemoglobin must be ≥12.5 g/dL * Hematocrit - Study donor's hematocrit must be ≥ ...