Assessment | STUDY PERIOD | ||||
---|---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | |
Baseline 7 days to 0 days | CPB initiation | Rewarming | Within 48 h after surgery | Surgery to discharge | |
Informed consent | √ | ||||
Inclusion/exclusion criteria | √ | ||||
Randomization | √ | ||||
Basic medical history | √ | ||||
Blood laboratory test | √ | √ | √ | √ | √ |
Blood gas analysis | √ | √ | √ | √ | √ |
Coagulation function | √ | √ | √ | ||
Coagulation factors | √ | √ | |||
Inflammatory factors | √ | √ | |||
Chest tube output | √ | √ | |||
Blood product transfusion | √ | √ | √ | √ | |
UDPB | √ | ||||
AE, SAE, and endpoints | √ | √ | √ | √ |