Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection
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ClinicalTrials.gov Identifier: NCT01651182 |
Recruitment Status :
Completed
First Posted : July 26, 2012
Last Update Posted : September 18, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Tumour Surgery | Drug: No tranexamic acid Drug: Tranexamic Acid | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Label, Non-Randomized, Study to Evaluate the Pharmacokinetics of Tranexamic Acid in Patients Undergoing Major Liver Resection |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Standard Care
No tranexamic acid
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Drug: No tranexamic acid
Control |
Experimental: Dose 1
1 g bolus + 1 g infusion from induction over 8 hours
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Drug: Tranexamic Acid
Other Name: Cyklokapron |
Experimental: Dose 2
1 g bolus + 10 mg/kg/hr from induction until end of surgery
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Drug: Tranexamic Acid
Other Name: 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651182
Canada, Ontario | |
Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 |
Principal Investigator: | Paul Karanicolas, MD PhD | Sunnybrook Health Sciences Centre |
Responsible Party: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT01651182 |
Other Study ID Numbers: |
TXA Liver - PK |
First Posted: | July 26, 2012 Key Record Dates |
Last Update Posted: | September 18, 2015 |
Last Verified: | September 2015 |
Blood transfusion Blood loss Postoperative complications Outcome |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents |
Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |