Blood Loss, Surgical
Conditions
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
Interventions
DRUGtranexamic acid diluted in 100 ml of saline solution (loading dose)
DRUGtranexamic acid undiluted (continous infusion)
DRUGPlacebo
Saline
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood loss (milliliters) | intraoperative (from skin incision to skin closure) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Outcome results
None listed