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Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial

PHASE3ACTIVE_NOT_RECRUITING

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.

Study details:

Delirium is a devastating complication of medical and perioperative care, associated with increased morbidity and mortality, dementia and impaired long-term cognition, and loss of independence. Delirium is also associated with neuronal injury placing patients at risk for long-term changes in cognition. There are no proven therapies for postoperative delirium, mainly due to the lack of adequately powered, biologically plausible trials.

There is growing evidence that tranexamic acid (TxA) may reduce inflammatory pathways in the central nervous system and protect the blood-brain barrier in trauma, and surgery. This sub-study of the TRIGS trial (www. trigs.

com. au) is evaluating the potential impact of TxA on the incidence and severity of delirium after surgery. TRIGS-D Study Aims: In a subset of 826 patients enrolled in the TRIGS randomized trial data will be collected to identify delirium incidence and severity.

The specific aims are to investigate whether TxA:. Aim 1: Reduces the incidence of postoperative delirium diagnosed with the 3D-CAM. Aim 2: Reduces the severity of delirium diagnosed with the 3D-CAM-Severity (3D-CAM-S).

Aim 3: Modulates inflammatory (plasma cytokines, innate cell immune profile) and neurophysiological (EEG) responses in concert with any alteration in the incidence or severity of delirium. Aim 4: Reduces longer-term impairment of quality of life and improves disability-free survival. Primary hypothesis: 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. Study Design: Multicentre, randomized, triple-blind, placebo-controlled, clinical trial (a sub-study of the TRIGS trial). Patients are randomly assigned to either TxA or matched placebo.

The incidence of postoperative delirium will be assessed daily using the 3D-CAM or CAM-ICU and medical record review for the first 3 days after surgery. In addition, follow up assessments will be done at 30 days and 12 months.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Adult patients scheduled for elective gastrointestinal (oesophageal, gastric, hepatobiliary, colorectal) surgery
  2. 2 or more risk factors for complications
  3. age ≥70 years
  4. American Society of Anesthesiologists (ASA) physical status 3 or 4
  5. heart failure
  6. diabetes
  7. chronic respiratory disease
  8. obesity (BMI ≥30 kg/m2)
  9. vascular disease
  10. preoperative haemoglobin <100 g/L
  11. renal impairment (se. creatinine ≥150 micromol/L), or low albumin (<30 g/L)
  12. Written informed consent will be obtained

Exclusion criteria

  1. Poor spoken and/or written language comprehension
  2. laparoscopic and other minor (eg. closure of stoma) surgery
  3. pre-existing infection/sepsis
  4. history of spontaneous pulmonary embolism or arterial thrombosis
  5. current arterial or venous thrombosis
  6. familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)
  7. contraindication to TxA

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

PREVENTION

phase

Phase

    PHASE3

trial

Study ID

NCT05470816

Intervention or treatment

DRUG: Tranexamic Acid 100Mg/ml Inj Vial 10ml

DRUG: Placebo

Conditions

  • Surgical Site Infection
  • Dementia
  • Cognition

  • Condition: Surgical Site Infection, Dementia and more

  • DRUG: Tranexamic Acid 100Mg/ml Inj Vial 10ml and other drugs

  • Melbourne, Victoria, Australia and more

  • Sponsor: Bayside Health

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Are you running this trial?

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Research sites nearby

Closest Location:

Alfred Health

Select from list below to view details:

  • Alfred Health

    Melbourne, Victoria, Australia

  • Alfred Health

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

BH

Bayside Health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Tranexamic Acid
  • 12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.
Drug: Tranexamic Acid 100Mg/ml Inj Vial 10ml
    PLACEBO_COMPARATOR: Placebo
    • 12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.
    Drug: Placebo

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      incidence of delirium in the first 3 days postoperatively3D-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 presentpost surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review

      Secondary Outcome

      MeasureDescriptionTime Frame
      Delirium severity3D-CAM-Spost surgical incision to day 3 (inclusive)
      Quality of Life Intergroup differencesusing the Short form survey 12 - Quality of Life Intergroup differences in long-term (12 month) in perioperative cognitive decline12 months post surgical incision
      DisabilityWorld Health Organization disability assessment schedule. Intergroup differences in long-term (12 month) in perioperative cognitive decline12 months post surgical incision
      perioperative neurocognitive disorders (NCDs)NCD will be defined as any of: (i) subjective complaint, (ii) a 4-point reduction in TICS-B, (iii) SF or VF, and (iv) functional deficit defined as a reduction in WHODAS score of 5% or more from baseline (before surgery).12 months post surgical incision
      Days at home up to 30 days after surgery (DAH30)DAH30 is patient-centred and reflects the patient's primary aim of a healthy recovery, reduced hospital costs and serious complications, and avoiding re-admission (often due to postoperative delirium).30 days post surgical incision post surgical incision
      cytokine levelsBlood tests measured in 92 key inflammatory/immune markers using technologypreoperative, postoperative day 1 and 3 post surgical incision
      neuronal injury biomarkerused to evaluate temporal changes in the innate cellular immune and inflammatory profile, and for changes in fibrinolysispreoperative, postoperative day 1 and 3 post surgical incision
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial

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