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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Kimberly Nuhanovic CCRP

(507)293-3905

Krull.Kimberly@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20467332

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