A Study to Evaluate Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection

Overview

About this study

The purpose of this study is to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. Participants enrolled in the prior Vanguard study will proceed directly into the RCT.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Patient scheduled for open or laparoscopic liver surgery.
Age ≥ 18 years old.

Exclusion Criteria:

Severe anemia (hemoglobin (Hgb) levels <90 g/l).
Documented arterial or venous thrombosis at screening or in past three months (not including therapeutic portal vein embolization).
Anticoagulants (other than low-molecular-weight heparin (LMWH) or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week.
Known disseminated intravascular coagulation.
Severe renal insufficiency (creatinine clearance (CrCl) <30 ml/min).
History of seizure disorder.
Pregnant or lactating (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation).
Acquired disturbance of colour vision - Hypersensitivity to TXA 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).
Previously enrolled in this study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Patrick Starlinger, M.D., Ph.D.	Closed for enrollment	Contact information: Kimberly Nuhanovic CCRP (507)293-3905 Krull.Kimberly@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Starlinger, M.D., Ph.D.

Closed for enrollment

Contact information:

Kimberly Nuhanovic CCRP

(507)293-3905

Krull.Kimberly@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials