Tranexamic Acid in Major Vascular Surgery
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2015
CompletedFirst Posted
Study publicly available on registry
January 9, 2015
CompletedStudy Start
First participant enrolled
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedMay 14, 2019
May 1, 2019
2.7 years
January 7, 2015
May 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Blood loss (milliliters)
intraoperative (from skin incision to skin closure)
Secondary Outcomes (3)
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
Study Arms (2)
Tranexamic Acid
EXPERIMENTALA 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 COMPARATORSaline
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 50
- Able to give written informed consent
- Undergoing open abdominal aortic aneurysm repair
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Raffaele Scientific Institute
Milan, 20132, Italy
Related Publications (1)
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.
PMID: 31607387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
January 7, 2015
First Posted
January 9, 2015
Study Start
March 4, 2015
Primary Completion
October 30, 2017
Study Completion
October 30, 2018
Last Updated
May 14, 2019
Record last verified: 2019-05