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. 2022 Dec 20;12(12):e068933. doi: 10.1136/bmjopen-2022-068933

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:
  • Venous thromboembolism

  • Arterial occlusion

  • Acute coronary syndrome

  • Acute respiratory distress syndrome (ARDS) at any point of the ICU stay, graded as mild, moderate or severe according to the 2012 Berlin definition of ARDS.30

From operation commencement up to hospital discharge or death.

ICU, intensive care unit.