Tranexamic Acid in Major Vascular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-04

Study Completion Date

2018-10-30

Brief Summary

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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

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Detailed Description

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Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

tranexamic acid undiluted (continous infusion)

Intervention Type DRUG

Placebo

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline

Interventions

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

Intervention Type DRUG

tranexamic acid undiluted (continous infusion)

Intervention Type DRUG

Placebo

Saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No