임상시험 레이더

primary efficacy outcome

Total blood loss within 24 hours of trial drug administration will be our primary efficacy outcome.

the initial 24 hours after study drug administration;

primary safety outcome

the primary safety outcome will be the incidence of a collapsed (one or more) composite of thrombotic events during the initial 7 postoperative days, including non-hemorrhagic strokes, myocardial injury after non-cardiac surgery (MINS), pulmonary embolism, hepatic artery embolism, portal vein thrombosis, bowel infarction, peripheral arterial thrombosis, symptomatic proximal venous thromboembolism.

the initial 7 postoperative days after study drug administration

Estimated blood loss based on physician's assessment within the initial 24 hours of trial drug administration.

Estimated loss will be recorded by the attending anesthesiologist who collect blood loss at the end of surgery by adding the blood volume recovered in the suction canisters, and the sponges (by weighing surgical sponges before and after surgical use), and then subtracted the irrigation fluid, lymph, bile, serum, ascites, urine, and other fluids solution volumes, and finally add the postoperative drainage volume in the intensive care unit.

within the initial 24 hours after trial drug administration

Postoperative abdominal tube drainage volume during the initial 72 hours

The cumulative volume of fluid collected from the intra-abdominal drainage tube(s) placed during liver transplantation. Drainage will be measured and recorded at regular intervals for the first 72 hours after study drug administration. The total amount (in milliliters) over this 72-hour period will be recorded.

within the initial 72 hours after study drug administration

Units of RBC transfused within 72 hours.

RBC transfusion will be based on clinical need, but generally initiated when intraoperative hemoglobin is less than 70 g/L\[40\].

within the initial 72 hours after study drug administration