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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Active Comparator | 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. |
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| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 100mg/ml |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Infection | defined by the US Centers for Disease Control (CDC) | from surgical incision to 30 days post surgical incision |
| Measure | Description | Time Frame |
|---|---|---|
| Red cell transfusion | Total units given | from surgical incision to hospital discharge (from index surgery) or 30 days. |
| Other healthcare-associated infections | sepsis, pneumonia, blood stream infection, UTI, etc; all using CDC-guided definitions |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S Myles, MD, DSc | Alfred Hospital and Monash University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31126915 | Background | 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. | |
| 31317130 |
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This decision will be made on a individual case by case basis, with formal request and review by the PI and steering committee.
Before recruitment of final patient
Patient and illness eligibility
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D006470 | Hemorrhage |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007049 | Iatrogenic Disease |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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double-blind, placebo-controlled, randomised trial of TxA versus placebo
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Matched TxA and placebo vials
| Drug |
Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug. |
|
| from surgical incision to 30 days |
| C-reactive protein | peak | Postoperative Day 3 (three days after surgical incision) |
| 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 |
| 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. |
| D020969 | Disease Attributes |