Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms

NCT02125890 | Completed Phase 3

• 1 other identifier: REB-13-91
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysms

Outcome Measures

Primary Outcomes (1)

• Clinically significant bleeding

  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.

  Participants will be followed for average length of stay, which is approximately two weeks

Secondary Outcomes (13)

• 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

• 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

Study Arms (1)

Tranexamic Acid

EXPERIMENTAL

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.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

two doses of Tranexamic Acid will be given to patients with rupture abdominal aortic aneurysms

Also known as: Cyklokapron

Tranexamic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead

Study Sites (1)

Jagadish Rao

Regina, Saskatchewan, S4P-0W5, Canada

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jagadish Rao, MD, FRCSC

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 29, 2014
• Study Start: July 1, 2014
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)