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Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery (TRIGS)

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ClinicalTrials.gov Identifier: NCT04192435
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Bayside Health

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
Infection Wound Gastrointestinal Complication Anesthesia Bleeding Healthcare Associated Infection Drug: Tranexamic Acid Drug: Placebos 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind, placebo-controlled, randomised trial of TxA versus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matched TxA and placebo vials
Primary Purpose: Treatment
Official Title: Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : January 31, 2026


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.




Primary Outcome Measures :
  1. Incidence of Surgical Site Infection [ Time Frame: from surgical incision to 30 days post surgical incision ]
    defined by the US Centers for Disease Control (CDC)


Secondary Outcome Measures :
  1. Red cell transfusion [ Time Frame: from surgical incision to hospital discharge (from index surgery) or 30 days. ]
    Total units given

  2. Other healthcare-associated infections [ Time Frame: from surgical incision to 30 days ]
    sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions

  3. C-reactive protein [ Time Frame: Postoperative Day 3 (three days after surgical incision) ]
    peak

  4. Days at home up to 30 days after surgery (DAH30). [ Time Frame: From surgical incision to 30 days ]
    Time that patient spends at home in the 30 days following surgery



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192435


Contacts
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Contact: Paul S Myles, MD, DSc +61390763176 ext 3176 p.myles@alfred.org.au
Contact: Sophie KA Wallace, MPH, RN +61390763176 ext 62651 s.wallace@alfred.org.au

Locations
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Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Sophie Wallace, MPH    +61390762651 ext 62651    s.wallace@alfred.org.au   
Principal Investigator: Paul S Myles, MB.BS, MPH, MD,FCARCSI,FANZC         
Sponsors and Collaborators
Bayside Health
National Health and Medical Research Council, Australia
Investigators
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Study Chair: Paul S Myles, MD, DSc Alfred Hospital and Monash University
Publications:
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Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT04192435    
Other Study ID Numbers: 087
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Before recruitment of final patient
Access Criteria: Patient and illness eligibility

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants