Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms
Status:
Completed
Trial end date:
2020-02-12
Target enrollment:
Participant gender:
Summary
An abdominal aortic aneurysm occurs when the part of the aorta travelling down into the
abdomen balloons out more than 50%. If caught early, treatments can be used to prevent
rupture of the aneurysm. However, many of these aneurysms are asymptomatic and go undetected
until they rupture, causing large amounts of blood to spill into the abdominal cavity and
typically leads to death, if left untreated. The current mortality rate is between 50 and
90%. The resources required to treat patients with ruptured aortic aneurysms is quite
substantial given that they need blood transfusions and can have prolonged hospital stays.
Patients either undergo a more invasive operative repair, associated with greater blood
products transfusions and complications, or if relatively stable, undergo a less invasive
repair with tubes called stents. There is less morbidity associated with the latter,
endovascular repair. To prevent blood loss in elective surgeries, drugs that promote blood
clotting are often used. One drug, tranexamic acid , has been shown to reduce blood loss,
reduce the number of blood transfusions required and improve patient outcomes in elective
cardiac and orthopaedic surgeries, and more recently, in patients with traumatic hemorrhage.
However, this drug has not been tested in this particular population. The purpose of this
pilot project is to evaluate the effectiveness of tranexamic acid in reducing clinically
significant bleeding in patients with ruptured aortic aneurysms in hospital sites across
Saskatchewan using a single-group intervention design. The investigators will compare the
data from patients treated with tranexamic acid to retrospective data from a control group
that is matched on key variables. The investigators predict that tranexamic acid will result
in reduced bleeding, reduced need for blood transfusions, less patients that require open
surgery and improved patient outcomes. The results of this study will help determine if this
treatment is effective at preventing the death of many people with ruptured abdominal aortic
aneurysms.
Phase:
Phase 3
Details
Lead Sponsor:
Regina Qu'Appelle Health Region Saskatchewan Health Authority - Regina Area