Cancer Clinical Trial
Official title:
Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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