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Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms (TARAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Regina Qu'Appelle Health Region
Sponsor:
Information provided by (Responsible Party):
Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier:
NCT02125890
First received: April 24, 2014
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Abdominal Aortic Aneurysms
Blood Transfusion Requirements
Drug: Tranexamic Acid administration
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by Regina Qu'Appelle Health Region:

Primary Outcome Measures:
  • Transfusion requirement [ Time Frame: Participants will be followed for average length of stay, which is approximately two weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will assess all cause 28 day mortality


Secondary Outcome Measures:
  • Blood transfusion requirement [ Time Frame: Patients will be followed during hospital length of stay, which is an average of two weeks ] [ Designated as safety issue: No ]
  • Number of blood transfusions [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Incidence of intrabdominal hypertension [ Time Frame: Patients will be followed during hospital length of stay, an average of two weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: July 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic Acid
We will be administering Tranexamic Acid in patient with ruptured aortic aneurysms to determine if this has an effect on primary outcome measures as significant bleeding, blood transfusion requirements.
Drug: Tranexamic Acid administration
Other Name: Cyklokarpon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125890

Contacts
Contact: Jagadish Rao, BSc, MSc, MD, FRCSC 306-766-6925 Jagadish.Rao@rqhealth.ca
Contact: Jennifer St.Onge, PhD 306-766-5533 Jennifer.StOnge@rqhealth.ca

Locations
Canada, Saskatchewan
Jagadish Rao Recruiting
Regina, Saskatchewan, Canada, S4P-0W5
Contact: Jagadish Rao, MD FRCSC    306-766-6925    Jagadish.Rao@rqhealth.ca   
Sub-Investigator: Jennifer St.Onge, PhD         
Sponsors and Collaborators
Regina Qu'Appelle Health Region
Investigators
Principal Investigator: Jagadish Rao, MD, FRCSC RQ Health Region
  More Information

No publications provided

Responsible Party: Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier: NCT02125890     History of Changes
Other Study ID Numbers: REB-13-91
Study First Received: April 24, 2014
Last Updated: November 3, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Aortic Aneurysm, Abdominal
Aneurysm
Aortic Aneurysm
Aortic Rupture
Aneurysm, Ruptured
Aortic Diseases
Cardiovascular Diseases
Rupture
Vascular Diseases
Wounds and Injuries
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014