A randomized, double-blind, placebo-controlled trial is currently being conducted across eleven academic hospitals in Germany to determine if tranexamic acid (TXA) can reduce the need for blood transfusions during major abdominal surgeries. The study, titled "Tranexamic Acid for reduction of intra- and postoperative TRansfusion requirements in major abdominal surgery (TRANSFUSE)," seeks to enroll 850 participants undergoing elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy. The primary goal is to assess whether TXA administration decreases the proportion of patients requiring at least one unit of packed red blood cells (PRBCs).
Study Design and Intervention
Eligible patients aged 18 years or older with adequate renal function are randomized to receive either TXA or a placebo (normal saline solution). Exclusion criteria include severe anemia, thrombocytopenia, bleeding disorders, recent thromboembolic events, or known hypersensitivity to TXA. The TXA intervention consists of a 1000 mg bolus administered intravenously over 10 minutes before skin incision, followed by a continuous infusion of 125 mg/hour until skin closure, with a maximum dose of 1000 mg. The comparator group receives a placebo of normal saline solution. All perioperative and operative procedures are carried out according to clinical standards, including the pausing or bridging of anticoagulants with low molecular weight heparin according to national and local guidelines.
Comprehensive Patient Blood Management
In addition to the TXA intervention, all participants receive basic patient blood management, including education initiatives, standard operating procedures, massive hemorrhage protocols, and coagulation and transfusion algorithms. Preoperative anemia is screened for, diagnosed, and treated, with intravenous iron administered if oral iron is not tolerated. Measures are also taken to reduce iatrogenic blood loss during diagnostic and surgical procedures.
Primary and Secondary Endpoints
The primary endpoint of the trial is the need for transfusion of at least one unit of PRBCs. Secondary endpoints include the number of transfused units per participant, the time between skin incision and the beginning of transfusion, estimated intraoperative blood loss, operation and anesthesia times, D-dimer levels before and after the operation, hemoglobin levels, duration of hospital stay, quality of life (assessed using the SF-12 questionnaire), and postoperative complications and mortality.
Statistical Analysis and Oversight
The primary endpoint will be compared between the two study arms using a logistic regression model, including treatment group, type of operation, and type of surgical access as covariates. Secondary endpoints will be analyzed using linear regression models, with time-to-event analysis used to compare time to transfusion between the arms. An independent Data Safety Monitoring Board (DSMB) monitors safety data and can recommend study modifications or termination if necessary. The trial is being conducted with the support of KKS Halle, which is responsible for data management, monitoring, and statistical analysis.
Expected Impact
The trial aims to determine whether TXA can reduce the need for blood transfusions in patients undergoing major abdominal surgery, potentially improving patient outcomes and reducing healthcare costs. The results will be disseminated through peer-reviewed publications, presentations at scientific conferences, and direct communication with relevant medical societies and patient organizations.
