Summarized results of the trials used for licensure of Intercept
| Results of the 2 licensing trials for Cerus platelets . | ||||
|---|---|---|---|---|
| . | EuroSprint . | SPRINT (apheresis trial) . | ||
| Characteristic . | Control units . | Control units . | Test units . | Control units . |
| Number of enrolled patients | 103 | 645 | ||
| Observation period | 56 | 28 | ||
| Mean platelet dose ( × 10e11) | 3.7* | 4.0 | 3.9* | 4.3 |
| Total platelet dose ( × 10e11) | 22.3 | 21.2 | 29.4* | 24.1 |
| Mean number of transfusions | 7.5 | 5.6 | 8.4* | 6.2 |
| Intertransfusion interval (days) | 3.0 | 3.4 | 1.9* | 2.4 |
| Mean CCI ( × 10e9/L) (1 h) | 28 | 36 | 12* | 34 |
| Mean CCI ( × 10e9/L) (24 h) | 16 | 25 | 13* | 22 |
| Mean CCI ( × 10e3) (1 h) | 13 | 14.9 | 11.1* | 16 |
| Mean CCI ( × 10e3) (24 h) | 7.5* | 10.6 | 6.4* | 10.1 |
| Results of the 2 licensing trials for Cerus platelets . | ||||
|---|---|---|---|---|
| . | EuroSprint . | SPRINT (apheresis trial) . | ||
| Characteristic . | Control units . | Control units . | Test units . | Control units . |
| Number of enrolled patients | 103 | 645 | ||
| Observation period | 56 | 28 | ||
| Mean platelet dose ( × 10e11) | 3.7* | 4.0 | 3.9* | 4.3 |
| Total platelet dose ( × 10e11) | 22.3 | 21.2 | 29.4* | 24.1 |
| Mean number of transfusions | 7.5 | 5.6 | 8.4* | 6.2 |
| Intertransfusion interval (days) | 3.0 | 3.4 | 1.9* | 2.4 |
| Mean CCI ( × 10e9/L) (1 h) | 28 | 36 | 12* | 34 |
| Mean CCI ( × 10e9/L) (24 h) | 16 | 25 | 13* | 22 |
| Mean CCI ( × 10e3) (1 h) | 13 | 14.9 | 11.1* | 16 |
| Mean CCI ( × 10e3) (24 h) | 7.5* | 10.6 | 6.4* | 10.1 |
The intertransfusion intervals are shortened in both trials.
P < .001.
CCI, corrected count increment.