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| Name | Class |
|---|---|
| University of Toronto | OTHER |
| University Health Network, Toronto | OTHER |
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Tranexamic acid (TXA) is an antifibrinolytic agent that has been shown to reduce blood loss and blood transfusion requirements in the following patient populations: multisystem trauma, liver transplantation, cardiac surgery and spine surgery. Patients undergoing major liver resection are at risk of severe perioperative blood loss and may also benefit from perioperative TXA administration.
This open label, non-randomized study to evaluate the pharmacokinetic and pharmacodynamic properties of two well studied dosing regimens of TXA will provide guidance in determining the optimal TXA dosing regimen for patients undergoing major liver resection. Compelling evidence of the effectiveness of TXA comes from the large multicentred, multi-national CRASH-2 trial where TXA was administered as a 1 g bolus + 1 g infusion over 8 hours. In liver transplant surgery, the following dose regimen has been shown to have great effect:10 mg/kg/h from the start of surgery until 2 hours after reperfusion of the liver transplant.
Although TXA is not currently approved for use in patients undergoing major liver resection, Health Canada has allowed the use of tranexamic acid for use in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Placebo Comparator | No tranexamic acid |
|
| Dose 1 | Experimental | 1 g bolus + 1 g infusion from induction over 8 hours |
|
| Dose 2 | Experimental | 1 g bolus + 10 mg/kg/hr from induction until end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No tranexamic acid | Drug | Control |
| |
| Tranexamic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of blood transfusion(s) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fibrinolytic Markers | Baseline - Postoperative Day 0-7 | |
| Pharmacokinetic Study | Baseline - Postoperative Day 0-7 | |
| Post-operative incidence of symptomatic venous thromboembolic event |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Paul Karanicolas, MD PhD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27765582 | Derived | Karanicolas PJ, Lin Y, Tarshis J, Law CH, Coburn NG, Hallet J, Nascimento B, Pawliszyn J, McCluskey SA. Major liver resection, systemic fibrinolytic activity, and the impact of tranexamic acid. HPB (Oxford). 2016 Dec;18(12):991-999. doi: 10.1016/j.hpb.2016.09.005. Epub 2016 Oct 18. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006470 | Hemorrhage |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Drug |
|
|
| 30 days |
| Other post-operative complications | 30 days |