A Phase 3 interventional study of No tranexamic acid and Tranexamic Acid in Cancer, Tumour and Surgery, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-18.
Sponsored by Sunnybrook Health Sciences Centre · Phase 3, Interventional, and Treatment
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.
Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
No tranexamic acid
Drug: No tranexamic acid
1 g bolus + 1 g infusion from induction over 8 hours
Drug: Tranexamic Acid
1 g bolus + 10 mg/kg/hr from induction until end of surgery
Drug: Tranexamic Acid
Control
Also known as: Cyklokapron
Receipt of blood transfusion(s)
Time frame: 7 days
Fibrinolytic Markers
Time frame: Baseline - Postoperative Day 0-7
Pharmacokinetic Study
Time frame: Baseline - Postoperative Day 0-7
Post-operative incidence of symptomatic venous thromboembolic event
Time frame: 30 days
Other post-operative complications
Time frame: 30 days
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre