TRIGS: Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA:
Aim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis).
Aim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30).
Aim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses.
Study Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tranexamic acid At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml. |
Drug: Tranexamic Acid
100mg/ml
|
| Placebo Comparator: Placebo At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml. |
Drug: Placebos
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Surgical Site Infection [from surgical incision to 30 days post surgical incision]
defined by the US Centers for Disease Control (CDC)
Secondary Outcome Measures
- Red cell transfusion [from surgical incision to hospital discharge (from index surgery) or 30 days.]
Total units given
- Other healthcare-associated infections [from surgical incision to 30 days]
sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions
- C-reactive protein [Postoperative Day 3 (three days after surgical incision)]
peak
- Days at home up to 30 days after surgery (DAH30). [From surgical incision to 30 days]
Time that patient spends at home in the 30 days following surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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)
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Anaemia (preoperative haemoglobin <130 g/l in males and <120 g/l in females)
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Renal impairment (se. creatinine ≥150mol/l)
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
Sponsors and Collaborators
- Bayside Health
- National Health and Medical Research Council, Australia
Investigators
- Study Chair: Paul S Myles, MD, DSc, Alfred Hospital and Monash University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
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