Clinical Trial: Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms

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

Detailed Summary:

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 im
Sponsor: Regina Qu'Appelle Health Region

Current Primary Outcome: Clinically significant bleeding [ Time Frame: Participants will be followed for average length of stay, which is approximately two weeks ]

Original Primary Outcome:

• Transfusion requirement [ Time Frame: Participants will be followed for average length of stay, which is approximately two weeks ]
  Hemoglobin less than 100 g/L, 2 or more units of red blood cells, 2 or more units of fresh frozen plasma (FFP), 5 or more units of cryoprecipitate, or more than 1 unit of platelets, or activation of the health region's Massive Transfusion Protocol.
• Number of ruptured abdominal aortic aneurysms requiring open laparotomy compared to endovascular stunting [ Time Frame: patients will be followed for length of stay in hospital, which is an average of two weeks ]
  We will compare the number of ruptured aortic aneurysms that require open repair with laparotomy versus those that can proceed with endovascular stenting.
• All cause 28 day mortality [ Time Frame: 28 days post-surgery ]
  We will assess all cause 28 day mortality

Current Secondary Outcome:

• Number of ruptured abdominal aortic aneurysms requiring open laparotomy compared to endovascular stunting [ Time Frame: Patients will be followed during hospital length of stay, which is an average of two weeks ]
  We will compare the number of ruptured aortic aneurysms that require open repair with laparotomy versus those that can proceed with endovascular stenting.
• Number of blood transfusions [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  We will examine the number of blood transfusions, including individual products
• Incidence of Transfusion Related Acute Lung Injury (TRALI) [ Time Frame: Patients will be followed during hospital length of stay, which is an average of two weeks ]
  TRALI refers to acute lung injury associated with transfusion of blood and blood products
• Incidence of Transfusion Related Reactions [ Time Frame: Patients will be followed during hospital length of stay, which is an average of two weeks ]
  This will examine the incidence of transfusion related reaction in patients with ruptured aneurysms
• Mechanical ventilator days [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  The number of days required by the patient on a ventilator will also be examined.
• Length of stay in ICU [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  Determination of length of stay in ICU
• Length of stay in hospital [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
• Incidence of intrabdominal hypertension [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  Incidence of intrabdominal hypertension may be related to blood products and resuscitation requirements.
• Incidence of Abdominal Compartment Syndrome (ACS) [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  We will examine the incidence of abdominal compartment syndrome (ACS)
• Requirement of either continuous or intermittent renal replacement therapy (dialysis) [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  If patients are hypotensive (low blood pressure), they will require vasoactive or inotropes for maintenance of blood pressure. These patients would not tolerate conventional intermittent hemodialysis. Instead, in this group, Continuous Renal Replacement Therapy would be the option. If the patient has normal blood pressure, and is not on vasoactive drugs, then intermittent renal replacement therapy would be acceptable.
• Cardiac morbidity [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  Cardiac morbidity such as cardiac arrest, myocardial infarction, stroke or seizure will be examined
• Multiorgan Dysfunction Score [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
• All cause 28 day mortality [ Time Frame: 28 days post-surgery ]
  We will assess all cause 28 day mortality

Original Secondary Outcome:

• Blood transfusion requirement [ Time Frame: Patients will be followed during hospital length of stay, which is an average of two weeks ]
• Number of blood transfusions [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  We will examine the number of blood transfusions, including individual products
• Incidence of Transfusion Related Acute Lung Injury (TRALI) [ Time Frame: Patients will be followed during hospital length of stay, which is an average of two weeks ]
  TRALI refers to acute lung injury associated with transfusion of blood and blood products
• Incidence of Transfusion Related Reactions [ Time Frame: Patients will be followed during hospital length of stay, which is an average of two weeks ]
  This will examine the incidence of transfusion related reaction in patients with ruptured aneurysms
• Mechanical ventilator days [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  The number of days required by the patient on a ventilator will also be examined.
• Length of stay in ICU [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  Determination of length of stay in ICU
• Length of stay in hospital [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
• Incidence of intrabdominal hypertension [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  Incidence of intrabdominal hypertension may be related to blood products and resuscitation requirements.
• Incidence of Abdominal Compartment Syndrome (ACS) [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  We will examine the incidence of abdominal compartment syndrome (ACS)
• Requirement of either continuous or intermittent renal replacement therapy (dialysis) [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  If patients are hypotensive (low blood pressure), they will require vasoactive or inotropes for maintenance of blood pressure. These patients would not tolerate conventional intermittent hemodialysis. Instead, in this group, Continuous Renal Replacement Therapy would be the option. If the patient has normal blood pressure, and is not on vasoactive drugs, then intermittent renal replacement therapy would be acceptable.
• Cardiac morbidity [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]
  Cardiac morbidity such as cardiac arrest, myocardial infarction, stroke or seizure will be examined
• Multiorgan Dysfunction Score [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ]

Dates:
Date Received: April 24, 2014
Date Started: July 2014
Date Completion: March 2018
Last Updated: November 1, 2016
Last Verified: November 2016