Tranexamic Acid in Major Vascular Surgery

Tranexamic Acid in Major Vascular Surgery. A Randomized Placebo-controlled Trial.

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 Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: Placebo; Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose); Drug: tranexamic acid undiluted (continous infusion)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • IRCCS San Raffaele Scientific Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline	Drug: Placebo; Saline
Experimental: Tranexamic Acid; A 500 mg loading dose of tranexamic acid diluted in 100 ml of saline solution will be slowly administered intravenously to patients 20 minutes before surgery, followed by a continuos infusion of 250 mg/h of tranexamic acid from surgical incision until skin closure.	Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose); Drug: tranexamic acid undiluted (continous infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood loss (milliliters)	intraoperative (from skin incision to skin closure)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of packed blood red cells transfused	hospital stay (an average of one week)
Occurrence of thromboembolic events (of any nature)	28-days and one year after surgery
Mortality	28-days and one year after surgery

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• Monaco F, Nardelli P, Pasin L, Barucco G, Mattioli C, Di Tomasso N, Dalessandro G, Giardina G, Landoni G, Chiesa R, Zangrillo A. Tranexamic acid in open aortic aneurysm surgery: a randomised clinical trial. Br J Anaesth. 2020 Jan;124(1):35-43. doi: 10.1016/j.bja.2019.08.028. Epub 2019 Oct 10.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2015
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 12, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Tranex-AAA/34/OSR