Anesthesia Clinical Trial
— TRIGSOfficial title:
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
NCT number | NCT04192435 |
Other study ID # | 087 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 18, 2022 |
Est. completion date | January 31, 2026 |
This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.
Status | Recruiting |
Enrollment | 3300 |
Est. completion date | January 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications: - Age =70 years - ASA physical status 3 or 4 - Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease - Obesity (BMI =30 kg/m2) - Anaemia (preoperative haemoglobin <130 g/l in males and <120 g/l in females) - Renal impairment (se. creatinine =150mol/l) - Low albumin (<30 g/L) Exclusion Criteria: - Poor spoken and or written language comprehension - Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery - Pre-existing infection/sepsis - Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden) |
Country | Name | City | State |
---|---|---|---|
Australia | Alfred Hospital | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Bayside Health | National Health and Medical Research Council, Australia |
Australia,
Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun. — View Citation
Draxler DF, Yep K, Hanafi G, Winton A, Daglas M, Ho H, Sashindranath M, Wutzlhofer LM, Forbes A, Goncalves I, Tran HA, Wallace S, Plebanski M, Myles PS, Medcalf RL. Tranexamic acid modulates the immune response and reduces postsurgical infection rates. Blood Adv. 2019 May 28;3(10):1598-1609. doi: 10.1182/bloodadvances.2019000092. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Surgical Site Infection | defined by the US Centers for Disease Control (CDC) | from surgical incision to 30 days post surgical incision | |
Secondary | Red cell transfusion | Total units given | from surgical incision to hospital discharge (from index surgery) or 30 days. | |
Secondary | Other healthcare-associated infections | sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions | from surgical incision to 30 days | |
Secondary | C-reactive protein | peak | Postoperative Day 3 (three days after surgical incision) | |
Secondary | Days at home up to 30 days after surgery (DAH30). | Time that patient spends at home in the 30 days following surgery | From surgical incision to 30 days |
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