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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date January 2023
Source Bayside Health
Contact Paul S Myles, MD, DSc
Phone +61390763176
Email p.myles@alfred.org.au
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Intervention

Drug:
Tranexamic Acid
100mg/ml
Placebos
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.

Locations

Country Name City State
Australia Alfred Hospital Melbourne Victoria

Sponsors (2)

Lead Sponsor Collaborator
Bayside Health National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (2)

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

Outcome

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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