Atrial Fibrillation Clinical Trial
— PAUSEOfficial title:
Perioperative Anticoagulant Use (Dabigatran, Rivaroxaban, or Apixaban) for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF).
Verified date | June 2019 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to establish a safe, standardized protocol for the perioperative management of patients with atrial fibrillation (AF) who are receiving a novel oral anticoagulant (DOAC) drug, either dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.
Status | Completed |
Enrollment | 3135 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 years or older 2. Receiving a DOAC (dabigatran or rivaroxaban or apixaban) for Atrial Fibrillation 3. Ability to assess patient at lease one day prior to DOAC discontinuation Exclusion Criteria: 1. CrCl less than 30 mL per min for dabigatran- and rivaroxaban-treated patients ( less than 25 mL per min for apixaban-treated patients) as estimated by Cockroft-Gault formula 2. Cognitive impairment or psychiatric illness that precludes collection of followup data 3. Inability or unwillingness to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Cardiovascular Sciences, University of Leuven | Leuven | |
Canada | University of Alberta | Edmonton | Alberta |
Canada | QEII Hospital | Halifax | Nova Scotia |
Canada | Hamilton General Hospital | Hamilton | Ontario |
Canada | Juravinski Hospital | Hamilton | Ontario |
Canada | McMaster University Medical Centre | Hamilton | Ontario |
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Canada | Maisonneuve-Rosemont | Montreal | Quebec |
Canada | Montreal General Hospital | Montreal | Quebec |
Canada | Montreal Jewish General Hospital | Montreal | Quebec |
Canada | St. Mary's Hospital | Montreal | Quebec |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | North York General | Toronto | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Canada | University of Manitoba | Winnipeg | Ontario |
Greece | Department of Anesthesiology, University of Thessaly | Larissa | |
Netherlands | Department of Vascular Medicine, Amsterdam Cardiovascular Sciences | Amsterdam | |
United States | Department of Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA | Aurora | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | NorthShore University HealthSystem | Evanston | Illinois |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada |
United States, Belgium, Canada, Greece, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dilute TT test-Laboratory blood test of NOAC levels | • DOAC levels will be measured by the dilute TT test expressed in ng/mL. | Day of Surgery | |
Other | Anti-Xa test for NOAC level | DOAC levels as measured by an anti-Xa tests, expressed in ng/mL. | Day of surgery | |
Other | INR Laboratory Test | • The INR will be done to compare these tests with novel oral anticoagulant specialized Anti-Xa tests | Day of surgery | |
Other | PT Laboratory test | PT will be measured to compare these tests with novel oral anticoagulant specialized Anti-Xa tests | Day of surgery | |
Other | aPTT Laboratory test | To compare these tests with novel oral anticoagulant specialized Anti-Xa tests | Day of Surgery | |
Other | TT Laboratory test | To compare these tests with novel oral anticoagulant specialized Anti-Xa tests | Day of surgery | |
Primary | Number of Participants with Major Bleeds | The first primary outcome is Major Bleed:Bleeding that is fatal or is symptomatic and retroperitoneal, intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or intra-articular. Non-surgical bleeding causing a drop in hemoglobin greater than or equal to 20 g per L or leading to transfusion greater or equal to 2 units of blood within 24 hours.Surgical bleed that leads to intervention or interferes with mobilization or leads to delayed wound healing; or leads to deep wound infection. Surgical site bleeding that is unexpected and prolonged and or sufficiently large to cause hemodynamic instability associated with a drop in hemoglobin greater or equal to 20 g per L or transfusion of greater or equal to 2 units of blood within 24 hours. The second primary outcome is atrial thromboembolism (ATE), comprising: Ischemic stroke,Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ or transient ischemic attack. |
Within 30 days of surgery or procedure | |
Primary | Number of participants with Atrial Thromboembolism | The second primary outcome is atrial thromboembolism (ATE), comprising: Ischemic stroke: any new focal neurologic deficit that persists for >24 hours or any new focal neurologic deficit of any duration, that occurs with evidence of acute infarction on computed tomography (CT) or magnetic resonance imaging (MRI) of the brain. Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ, confirmed intra-operatively or by objective imaging studies (e.g. CT angiography). Transient ischemic attack: symptomatic focal neurologic deficit (lasting typically less than 1 hour), that occurs with no evidence of acute infarction on CT or MRI of brain. |
Within 30 days of surgery or procedure | |
Secondary | Number of participants with Minor bleeding | • Minor bleeding: bleeding not satisfying criteria for major bleeding; investigator will report bleeding events using pertinent clinical data and with an assessment from the surgeon. | 30 days or less after surgery or porcedure | |
Secondary | Number of participants who die | Death: death due to any cause. | 30 days or after surgery or procedure | |
Secondary | Number of participants that have a Venous Thromboembolism (VTE) | Venous thromboembolism (VTE): comprising symptomatic deep vein thrombosis and pulmonary embolism, confirmed by objective imaging studies (e.g., ultrasound, CT pulmonary angiogram). | 30 days or less after surgery | |
Secondary | Number of participants who acquire Acute Coronary Syndrome | • Acute coronary syndrome: symptomatic myocardial ischemia, defined by pre-specified clinical and objective EKG- and/or troponin-related criteria N.B. Patients who develop any clinical outcome will be treated according to standards of care. | 30 days or less after surgery or procedure |
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