Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial

primary efficacy outcome

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

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.

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.

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.

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\[40\].

The incidence of early allograft dysfunction (EAD) or primary nonfunction (PNF) within the initial 7 postoperative days.

EAD is defined according to Olthoff's criteria as one of the following: (a) bilirubin ≥ 10 mg/dL on day 7; or (b) INR ≥ 1.6 on day 7; or (c) AST/ ALT \> 2000 IU/L within first 7 days. PNF is defined as graft loss, re-transplantation, or patient death due to graft non-function in first 30 days (excluding non-function secondary to hepatic artery thrombosis, biliary complications, or recurrent hepatic disease).

Acute Kidney Injury (AKI) stage within the initial 7 postoperative days as defined by KDIGO

The stages of Acute Kidney Injury (AKI) within first 7 days which is defined according to KDIGO (Kidney Disease Improving Global Outcomes criteria\[33\]: Stage 1 (a) increase in SCr by 0.3 mg/dl within any 48-hour window; or (b) increase in SCr to 1.5 times of baseline within the past 7 days; or (c) urine output less than 0.5 ml/kg/h for 6 hours. Stage 2 (a) increase in SCr to 2.0 times of baseline within the past 7 days; (b) urine output less than 0.5 ml/kg/hour for more than 12 hours.

Surgical complications and related Clavien Dindo classification within 30 days of surgery

Total hours of mechanical ventilation after surgery