Cancer, Surgery, Tumour
Conditions
Keywords
Blood transfusion, Blood loss, Postoperative complications, Outcome
Brief summary
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.
Interventions
Control
DRUGTranexamic Acid
Sponsors
University of Toronto
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient undergoing anticipated open or laparoscopic major liver resection (\> 2 hepatic segments), as assessed by the operating surgeon * Age ≥ 18 years.
Exclusion criteria
* Previously enrolled in this study * Platelet count less than 100,000/mm3 * Severe anemia (hemoglobin levels less than 90 g/l) * Documented arterial or venous thrombosis at screening or in past three months * Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week * Hepatectomy associated with planned vascular or biliary reconstruction * Known disseminated intravascular coagulation * Severe renal insufficiency (CrCl\<30) * History of seizure disorder * Pregnant or lactating * Hypersensitivity to tranexamic acid or any of the ingredients * Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction) * Receipt of chemotherapy within 4 weeks of scheduled operation * Patients undergoing resection for living donor liver transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Receipt of blood transfusion(s) | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Fibrinolytic Markers | Baseline - Postoperative Day 0-7 |
| Pharmacokinetic Study | Baseline - Postoperative Day 0-7 |
| Post-operative incidence of symptomatic venous thromboembolic event | 30 days |
| Other post-operative complications | 30 days |
Countries
Canada
Outcome results
None listed