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OpenTrials
Completed

NCT Number: NCT02335359

Tranexamic Acid in Major Vascular Surgery

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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Key information

Conditions

Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

tranexamic acid undiluted (continous infusion)

Drug

Placebo

Drug

Saline

Primary outcomes

  1. Blood loss (milliliters)

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

Secondary outcomes

  1. Number of packed blood red cells transfused

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

  2. Occurrence of thromboembolic events (of any nature)

    Time frame: 28-days and one year after surgery

  3. Mortality

    Time frame: 28-days and one year after surgery

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 9, 2015
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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