Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms

• Status: Completed
• Trial end date: 2020-02-12
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regina Qu'Appelle Health Region; Saskatchewan Health Authority - Regina Area
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• any patient with a ruptured aortic aneurysm, regardless of sex, age, ethnicity who may or may not be on anticoagulant or anti-platelet medications for comorbid conditions.

Exclusion Criteria:

• pregnancy

• hypersensitivity to Tranexamic Acid (TXA)

• acquired defective colour vision

• active intravascular clotting or disseminated intravascular clotting (DIC)

• subarachnoid hemorrhage

• thromboembolic disease

• age < 18 years of age

• known clotting disorder

• patients receiving thrombin