The Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Clinically significant bleeding
Study Overview
Brief 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.
Detailed Description
The primary purpose of this study is to examine the effectiveness of TXA in reducing clinically significant bleeding in a novel patient population (ruptured AAA). The first phase of this study will involve a small pilot project, consisting of ~25 patients who will be administered TXA during their treatment for a ruptured AAA. We will compare the amount of clinically significant bleeding from a group of patients treated prospectively with TXA to data collected retrospectively over the previous year from a matched control group of patients who were treated for a ruptured AAA but not given TXA. At the conclusion of this pilot, if the data reveal that administration of TXA in patients with ruptured AAA reduces the incidence of clinically significant bleeding, then we will proceed to a multicenter national trial to determine the generalizability of TXA use to treat ruptured AAA in patients across Canada.
METHODOLOGY This study employs a 1-year prospective non-randomized intervention design. All patients that present to a southern Saskatchewan hospital with a clinically-confirmed ruptured AAA during the 1-year enrollment period will be potential participants. We aim to enroll 25 consecutive patients with ruptured AAA.
Regina (Regina General Hospital) is the primary site for this study. Rural hospitals in the surrounding area that refer patients to Regina for trauma surgery will be the secondary sites. Local Health Canada Qualified Investigators will be responsible for the managing the study at each hospital
Diagnosis Patients presenting to a Saskatchewan emergency room (ER) with symptoms of a ruptured AAA might have an ultrasound or CT scan to confirm diagnosis as part of investigations. The current standard of care, however, is clinical assessment, which may be aided by prior imaging history of an unruptured AAA. Enrollment without radiologic confirmation at the time of presentation to the ER would take place upon the recommendation of the vascular surgeon in Regina. At that time, the patient's pharmaceutical history will be examined using the Pharmaceutical Information Program (PIP) system to determine if the patient has any contradictions to TXA as listed above for patients in Saskatchewan. Since other provinces do not have the PIP program, the study will be restricted to patients with Saskatchewan Health Cards.
For patients that meet the study inclusion criteria and none of the exclusion criteria, we will proceed with a three-part informed consent procedure based on the individual case (i.e., patient is conscious and capable of giving informed consent, patient is incapable of giving informed consent so the patient's next-of-kin or legally authorized representative will provide verbal or written consent, or patient is incapable of giving consent and there is no next-of-kin or legally authorized representative that can be contacted in a timely manner (30 minutes) so "Dual Physician Consent" will be used).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Tranexamic Acid
We will be administering Tranexamic Acid in patients with ruptured abdominal aortic aneurysms to determine if this has an effect on primary outcome measures as significant bleeding, blood transfusion requirements.
Intervention: Tranexamic Acid (Drug)
Outcomes
Primary Outcomes
Clinically significant bleeding
Time Frame: Participants will be followed for average length of stay, which is approximately two weeks
Hemoglobin less than 100 g/L or 2 or more units of red blood cells or 2 or more units of fresh frozen plasma (FFP), or 5 or more units of cryoprecipitate, or more than 1 unit of platelets, or activation of the health region's Massive Transfusion Protocol.
Secondary Outcomes
- Length of stay in ICU(Patients will be followed during hospital length of stay, an average of two weeks)
- Number of blood transfusions(Patients will be followed during hospital length of stay, an average of two weeks)
- Incidence of Transfusion Related Acute Lung Injury (TRALI)(Patients will be followed during hospital length of stay, which is an average of two weeks)
- Incidence of Transfusion Related Reactions(Patients will be followed during hospital length of stay, which is an average of two weeks)
- Mechanical ventilator days(Patients will be followed during hospital length of stay, an average of two weeks)
- Number of ruptured abdominal aortic aneurysms requiring open laparotomy compared to endovascular stunting(Patients will be followed during hospital length of stay, which is an average of two weeks)
- Length of stay in hospital(Patients will be followed during hospital length of stay, an average of two weeks)
- Incidence of intrabdominal hypertension(Patients will be followed during hospital length of stay, an average of two weeks)
- Incidence of Abdominal Compartment Syndrome (ACS)(Patients will be followed during hospital length of stay, an average of two weeks)
- Requirement of either continuous or intermittent renal replacement therapy (dialysis)(Patients will be followed during hospital length of stay, an average of two weeks)
- Cardiac morbidity(Patients will be followed during hospital length of stay, an average of two weeks)
- Multiorgan Dysfunction Score(Patients will be followed during hospital length of stay, an average of two weeks)
- All cause 28 day mortality(28 days post-surgery)