The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting. The main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery? Participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
850
Intravenous administration
Intravenous administration
University Hospital Carl Gustav Carus Dresden
Dresden, Saxony, Germany
RECRUITINGUniversity Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery
Halle, Germany
RECRUITINGTransfusion necessity
Intra- or postoperative transfusion of at least one unit of packed red blood cells
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Transfusion amount
Number of transfused units of packed red blood cells per patient
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Blood loss
Estimated intraoperative blood loss
Time frame: From skin incision to suture
Postoperative complications and mortality
Postoperative complications and mortality assessed according to the Clavien-Dindo scheme
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Length of hospital stay
Time period from hospital admission to discharge
Time frame: From hospital admission to discharge
Operation time
Time period from skin incision to suture
Time frame: From skin incision to suture
Anesthesia time
Time period from anesthesia induction to end of anesthesia
Time frame: From anesthesia induction to end of anesthesia
D-dimer levels
Serum levels of D-dimers
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
Adverse events
Any adverse event attributed to the intervention comprising anaphylaxis, thromboembolic events, acute renal failure, acute heart failure, seizures
Time frame: Until hospital discharge or 30 days postoperatively, whatever occurs earlier
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