Tranexamic Acid in Major Vascular Surgery

IRCCS San Raffaele100 enrolled

Overview

The purpose of this study is to determine whether tranexamic acid is effective in reducing intraoperative blood loss and necessity for haemotransfusion in patients undergoing open abdominal aortic aneurysm repair

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Blood Loss, Surgical

Interventions

tranexamic acid diluted in 100 ml of saline solution (loading dose)DRUG

tranexamic acid undiluted (continous infusion)DRUG

PlaceboDRUG

Saline

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 50 * Able to give written informed consent * Undergoing open abdominal aortic aneurysm repair Exclusion Criteria: * Patients participating in a pharmaceutical clinical trial in the last 3 months * Urgent/emergent surgery * Allergy/intolerance to tranexamic acid * History of seizures * Acute Venous or Arterial Thrombosis * Fibrinolytic conditions due to consumption coagulopathy * Disseminated intravascular coagulation * Haematuria * Visual disturbances

Locations (1)

IRCCS San Raffaele Scientific Institute

Milan, Italy

Outcomes

Primary Outcomes

Blood loss (milliliters)

Time frame: intraoperative (from skin incision to skin closure)

Secondary Outcomes

Number of packed blood red cells transfused

Time frame: hospital stay (an average of one week)

Occurrence of thromboembolic events (of any nature)

Time frame: 28-days and one year after surgery

Mortality

Time frame: 28-days and one year after surgery

Data from ClinicalTrials.gov

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