Tranexamic Acid 100Mg/ml Inj Vial 10ml: Intervention is from the Tranexamic acid to Reduce Infection after Gastrointestinal Surgery: the TRIGS Trial. A multicentre, pragmatic, double-blind, randomised clinical trial will compare the incidence of surgical site infection and red cell transfusion requirements after IV tranexamic acid and placebo in patients undergoing gastrointestinal surgery
Placebo: Normal saline
Study summary
Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients scheduled for elective gastrointestinal (oesophageal, gastric, hepatobiliary, colorectal) surgery
* with 2 or more risk factors for complications:
* age ≥70 years,
* American Society of Anesthesiologists (ASA) physical status 3 or 4,
* heart failure, diabetes,
* chronic respiratory disease,
* obesity (BMI ≥30 kg/m2),
* vascular disease,
* preoperative haemoglobin \<100 g/L,
* renal impairment (se. creatinine ≥150 micromol/L), or low albumin (\<30 g/L).
* Written informed consent will be obtained. Exclusion criteria
* Poor spoken and/or written language comprehension,
* laparoscopic and other minor (eg. closure of stoma) surgery,
* pre-existing infection/sepsis,
* history of spontaneous pulmonary embolism or arterial thrombosis,
* current arterial or venous thrombosis,
* familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden),
* contraindication to TxA.
Primary outcome measure(s)
incidence of delirium in the first 3 days postoperatively — post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review 3D-Confusion Assessment Method (3D-CAM) or CAM-ICU if the Used to measure delirium. Assessments will be conducted twice daily A classification of delirium will be made if both features 1 and 2 are present
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.