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Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding in Patients Undergoing Major Liver Resection: A Pilot, Randomized Controlled Trial

Phase 4
18 Years
Not Enrolling
Cancer, Tumour, Surgery

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Trial Information

Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding in Patients Undergoing Major Liver Resection: A Pilot, Randomized Controlled Trial

Liver resection remains the optimal treatment for patients with primary or metastatic liver
malignancies, benign liver tumors, and some biliary diseases. Despite improvements such as
advances in preoperative imaging and evaluation of liver functional reserve, extensive
intraoperative blood loss remains a major risk factor for postoperative morbidity and
mortality, as well as long-term survival after liver resection.

Several strategies to reduce blood loss during liver resection have been developed and
tested including operative and non-operative interventions. Operatively, surgeons may use
sophisticated methods of liver dissection and parenchymal transection including ultrasonic
dissectors, hydrodissectors, bipolar cautery, stapling devices, and more. Surgeons may also
selectively reduce the blood flow to the liver during liver resection by continuously or
intermittently clamping the portal vein and hepatic artery (the Pringle Maneuver). The
anaesthesiologist has a crucial role in reducing blood loss and transfusion requirements by
maintaining a low central venous pressure (CVP) during parenchymal transection. These
advances have resulted in substantially less blood loss during liver surgery compared with
prior decades, however bleeding remains a problem during major liver resection with up to
30-40% of patients in recent series receiving blood products.

Inclusion Criteria:

- Patient undergoing anticipated major liver resection (> 2 hepatic segments), as
assessed by the operating surgeon

- Age >18

Exclusion Criteria:

- Previously enrolled in this study

- Platelet count less than 100,000/mm3

- Known hereditary coagulopathy (INR>1.5)

- 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

- Cirrhosis

- Hepatectomy associated with planned vascular or biliary reconstruction

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Receipt of blood transfusion(s)

Outcome Description:

Transfusion of any blood product (red blood cells, fresh frozen plasma, platelets, or albumin) will be guided by a standardized protocol. Red blood cells will be transfused for Hgb<70, or Hgb 70-90 based on medical judgment with an indication provided by the transfusing clinician (coronary ischemia, hemodynamic instability, ongoing blood loss, etc). Fresh frozen plasma will be transfused for INR > 1.5 with active bleeding. Platelets will be transfused only if the patient is bleeding with platelet count < 50 x 109/L and cryoprecipitate only if patient is bleeding with fibrinogen < 1.0 g/L.

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Paul Karanicolas, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre


Canada: Health Canada

Study ID:




Start Date:

September 2012

Completion Date:

December 2013

Related Keywords:

  • Cancer
  • Tumour
  • Surgery
  • Blood transfusion
  • Blood loss
  • Postoperative complications
  • Outcome
  • Hemorrhage