Tranexamic Acid Versus Placebo for Blood to Reduce Perioperative Bleeding Post-liver Resection
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss in patients undergoing major liver resection.
Liver resection remains the optimal treatment for patients with primary or metastatic liver disease. However, extensive intraoperative blood loss remains a major risk factor for postoperative morbidity and mortality, as well as long-term survival after liver resection. Furthermore, risks of blood transfusion itself include transfusion-related acute lung injury, transfusion-associated circulatory overload, acute hemolytic transfusion reactions, bacterial contamination and severe allergic reactions.
Drug: Normal saline
Drug: Tranexamic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding in Patients Undergoing Major Liver Resection: A Pilot, Randomized Controlled Trial|
- Receipt of blood transfusion(s) [ Time Frame: 7 days ] [ Designated as safety issue: No ]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.
- Total blood loss as assessed by Gross' formula [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Intraoperative blood loss assessed by adding net weight of sponges and fluid suction (minus irrigation) [ Time Frame: Duration of anaesthesia ] [ Designated as safety issue: No ]
- Total volume of blood transfused [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Post-operative incidence of symptomatic venous thromboembolic event [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Other post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Normal saline||Drug: Normal saline|
|Active Comparator: Tranexamic Acid||
Drug: Tranexamic Acid
Patients will be administered a single dose of 1g tranexamic acid intravenously, immediately after induction of anaesthesia followed by 1g infusion over 8 hours.
Other Names:Drug: Tranexamic Acid
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.
|Contact: Jenny Lam-MCulloch||416-480-6100 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Paul Karanicolas, MD PhD 416-480-4832 email@example.com|
|Contact: Jenny Lam-McCulloch, MSc 416-480-6100 ext 85391 jenny.lam-McCulloch@sunnybrook.ca|
|Principal Investigator: Paul Karanicolas, MD PhD|
|Principal Investigator:||Paul Karanicolas, MD PhD||Sunnybrook Health Sciences Centre|