Clinical trial NCT04192435: Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
Official title: Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infection Wound
Gastrointestinal Complication
Anesthesia
Bleeding
Healthcare Associated Infection
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2019-12-10
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, placebo-controlled, randomised trial of TxA versus placebo
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of Surgical Site Infection
timeFrame: from surgical incision to 30 days post surgical incision
Secondary outcomes:
measure: Red cell transfusion
timeFrame: from surgical incision to hospital discharge (from index surgery) or 30 days.
measure: Other healthcare-associated infections
timeFrame: from surgical incision to 30 days
measure: C-reactive protein
timeFrame: Postoperative Day 3 (three days after surgical incision)
measure: Days at home up to 30 days after surgery (DAH30).
timeFrame: From surgical incision to 30 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Alfred Hospital and Monash University
name: Paul S Myles, MD, DSc
role: STUDY_CHAIR
References:
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.
citation: 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.