Table 3.
Trial primary and secondary outcome measures
| Primary | Time frame |
| Volume of postsurgical chest drain bleeding | The first 24 hours from the time of ICU admission |
| Secondary | |
| Total volume of postsurgical chest drain bleeding | From time of ICU admission up to removal of drains, death or day 28, whichever occurs first |
| Composite bleeding outcome using the Bleeding Academic Research Consortium (BARC4) criteria (intracranial bleeding within 48 hours; reoperation after closure of sternotomy; transfusion of ≥5 units whole blood or RBCs (red blood cells) within the 48 hour intraoperative or postoperative period (excluding cell saver blood); chest tube output ≥2 L within a 24-hour period)32 | Up to ICU discharge, death or day 90, whichever occurs first |
| No of units of RBC transfused in the first 24 hours after admission to ICU | The first 24 hours from the time of ICU admission. |
| Total no of units of red blood cells transfused by the time of ICU discharge, including intraoperative transfusion | From operation commencement up to ICU discharge, death or day 7, whichever occurs first. |
Occurrence of any one of the following specified adverse events/potential adverse events:
|
From operation commencement up to hospital discharge or death. |
ICU, intensive care unit.