- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02125890
Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms (TARAA)
The Effect of Tranexamic Acid in Ruptured Abdominal Aortic Aneurysms
Study Overview
Status
Conditions
Intervention / Treatment
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).
TXA Administration Patients who have an ultrasound or CT in a hospital/care centre outside of the catchment area Regina (rural patients) will receive the first dose of TXA (one gram IV over ten minutes) by the local attending physician (ER or family physician). For patients who are diagnosed in Regina, the vascular surgeon will be responsible for ordering TXA upon diagnosis in the emergency room. Rural patients in the Regina catchment area will then be transferred to the trauma center in Regina and the vascular surgeon will be notified that the patient is part of the study and has received TXA. For all patients, the second dose of TXA (one gram IV will be administered over 8 hours) will be ordered by the vascular surgeon or anesthesiologist in the ER, the OR theatre or the intensive care unit in Regina. Dosing recommendations are based on data resulting from the CRASH-2 Trial.30
If the patient stabilizes as a result of the TXA administration, the patient will proceed to the angiogram suite (interventional radiology) where a vascular surgeon will perform endovascular stenting. If the patient becomes or remains hemodynamically unstable after arrival, the patient will proceed to the operating room for laparotomy and open repair of the aneurysm. Procedures and subsequent treatment will remain the same as the current standard of care for ruptured AAA's. We will only collect data on the patient and his/her care during the patient's stay in hospital. Given that there is little risk of adverse events occurring from administration of TXA after hospital stay, once the patient has been released from hospital, there will be no direct follow-up.
Statistical analysis We will compare data from the experimental group (TXA) to the data from the matched control patients collected retrospectively (controls). The patients will be matched on age, sex, ethnicity, history of peripheral vascular disease, coronary artery disease, aneurysms, and current medications (antihypertensives, anticoagulants, NSAIDs). Our primary analyses will compare outcomes that are measured on interval/ratio scales using independent t-tests or ANOVA's or non-parametric Mann-Whitney/Kruskal-Wallis if the data are skewed. For categorical data, chi-square or Fisher's Exact tests with effect size measures will be used to analyze the relationship between treatment and outcome (e.g. incidence of abdominal compartment syndrome in experimental vs. control group). We will use two-sided tests with alpha set at .05 to be able to detect if TXA produces worse outcomes than standard treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4P-0W5
- Jagadish Rao
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
two doses of Tranexamic Acid will be given to patients with rupture abdominal aortic aneurysms
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Participants will be followed for average length of stay, which is approximately two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
Patients will be followed during hospital length of stay, an average of two weeks
|
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
|
Patients will be followed during hospital length of stay, which is an average of two weeks
|
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
|
Patients will be followed during hospital length of stay, which is an average of two weeks
|
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.
|
Patients will be followed during hospital length of stay, an average of two weeks
|
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
|
Patients will be followed during hospital length of stay, an average of two weeks
|
Length of stay in hospital
Time Frame: Patients will be followed during hospital length of stay, an average of two weeks
|
Determination of length of stay in hospital
|
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.
|
Patients will be followed during hospital length of stay, an average of two weeks
|
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)
|
Patients will be followed during hospital length of stay, an average of two weeks
|
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.
|
Patients will be followed during hospital length of stay, an average of two weeks
|
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
|
Patients will be followed during hospital length of stay, an average of two weeks
|
Multiorgan Dysfunction Score
Time Frame: Patients will be followed during hospital length of stay, an average of two weeks
|
A scoring system that measures dysfunction in six organ systems.
|
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
|
28 days post-surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jagadish Rao, MD, FRCSC, Saskatchewan Health Authority - Regina Area
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB-13-91
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Aortic Aneurysms
-
Cook Group IncorporatedCompletedAbdominal Aortic Aneurysms | Aorto-iliac Aneurysms | Iliac AneurysmsUnited States, China, Germany, Sweden, Russian Federation
-
Cook Group IncorporatedCompletedAbdominal Aortic Aneurysms | Aorto-iliac Aneurysms | Juxtarenal AneurysmsUnited States
-
Cook Research IncorporatedCompletedAbdominal Aortic Aneurysms | Iliac Aneurysms | Aortoiliac AneurysmsUnited States, Canada
-
Cook Group IncorporatedNo longer availableAbdominal Aortic Aneurysms | Aorto-iliac Aneurysms | Iliac AneurysmsUnited States
-
Cook Group IncorporatedApproved for marketingAbdominal Aortic Aneurysms | Aorto-iliac Aneurysms | Juxtarenal AneurysmsUnited States
-
Rijnstate HospitalW.L.Gore & AssociatesActive, not recruitingAneurysm | Abdominal Aortic Aneurysms | Common Iliac AneurysmsItaly, New Zealand, Netherlands, Spain
-
Endospan Ltd.CompletedAortoiliac Aneurysms | Infrarenal Abdominal Aortic AneurysmsItaly, Serbia, Netherlands, Switzerland
-
Gustavo OderichCook Group IncorporatedRecruitingJuxtarenal Aortic Aneurysms | Suprarenal Aortic Aneurysms | Type IV Thoracoabdominal Aortic AneurysmsUnited States
-
University of WashingtonRecruiting
-
Medtronic CardiovascularCompletedAbdominal Aortic AneurysmsUnited States
Clinical Trials on Tranexamic Acid
-
Icahn School of Medicine at Mount SinaiRecruiting
-
University of LiegeCompletedArthroplasty Complications | Hemorrhage Postoperative | Total Blood LossBelgium
-
London School of Hygiene and Tropical MedicineCompleted
-
Samsung Medical CenterUnknownBleeding | Transfusion Related ComplicationKorea, Republic of
-
Ain Shams UniversityCompleted
-
Aswan University HospitalCompletedCesarean Section ComplicationsEgypt
-
Assiut UniversityCompleted
-
Thammasat UniversityCompleted
-
Ferring PharmaceuticalsCompleted
-
London School of Hygiene and Tropical MedicineRawalpindi Medical CollegeCompletedPregnancy, High RiskPakistan, Zambia