Tranexamic Acid in Major Vascular Surgery

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335359
• Other study ID #: Tranex-AAA/34/OSR
• Status: Completed
• Phase: Phase 4
• Start date: March 4, 2015
• Est. completion date: October 30, 2018

Study information

• Verified date: May 2019
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

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

• tranexamic acid undiluted (continous infusion)

• Placebo
Saline

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss (milliliters)		intraoperative (from skin incision to skin closure)
Secondary	Number of packed blood red cells transfused		hospital stay (an average of one week)
Secondary	Occurrence of thromboembolic events (of any nature)		28-days and one year after surgery
Secondary	Mortality		28-days and one year after surgery