Tranexamic Acid in Major Vascular Surgery

Phase 4

Completed

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

• Registration Number: NCT02335359
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-09
• Study Start: 2015-03-04
• Primary Completion: 2017-10-30
• Study Completion: 2018-10-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-12
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	tranexamic acid diluted in 100 ml of saline solution (loading dose)	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.
Tranexamic Acid	tranexamic acid undiluted (continous infusion)	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.
Placebo	Placebo	Saline

Primary Outcome Measures

Name	Time	Method
Blood loss (milliliters)	intraoperative (from skin incision to skin closure)

Secondary Outcome Measures

Name	Time	Method
Mortality	28-days and one year after surgery
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

Trial Locations

Locations (1)

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Italy