An observational study in Atrial Fibrillation, sponsored by McMaster University. Completed at 21 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by McMaster University · 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.
The primary aim is to demonstrate that a standardized but patient-focused protocol for the perioperative management of each DOAC is safe, with acceptably low rates of perioperative major bleeding (MB) and arterial thromboembolism (ATE). The perioperative protocol is adjusted based on patient renal function and surgery/procedure-related bleed risk, to optimize patient safety, and does not involve heparin bridging anticoagulation.
The secondary aim of the PAUSE Study is to determine the effect of the pre-operative DOAC interruption protocol on the level of residual anticoagulation, when measured by 'everyday' coagulation tests that are not DOAC-specific (e.g., activated partial thromboplastin time [aPTT]) and 'specialized' coagulation tests that are DOAC-specific (dilute thrombin time [TT] - HemoclotTM, and anti-factor Xa assays).
Approximately 3,300 patients from 15 to 25 centres over a 3.5 year period will be recruited across Canada for the PAUSE Study.
Patients with Atrial Fibrillation and are currently taking dabigatran, rivaroxaban and apixaban (DOACs) and require elective surgery/procedure will follow a standardized management perioperative protocol for discontinuation of their DOAC prior to surgery. Patients will be discontinuing the DOAC they are currently receiving from 1 to 4 days prior to surgery or procedure, depending on bleed risk, type of DOAC, and creatinine clearance rate.
A blood sample will be taken on the day of the surgery or procedure for measurement of laboratory outcomes (residual level of anticoagulant on day of surgery).
Patients will be followed up weekly up to a month for primary outcome assessments.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 3,135 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Those patients who are currently taking dabigatran, rivaroxaban or apixaban for oral anticoagulation used for stroke prevention in atrial fibrillation, and who require its temporary interruption for a surgical or other procedure, will be recruited from 15 to 25 participating sites across Canada.
The study plans to screen 4,114 patients over a 3 year period, with 80 per cent expected enrollment (3,291 patients) from 16 sites across Canada. Equal number of patients, per oral anticoagulant arm will be enrolled, with approximately 1,000 patients taking each DOAC.
Exclusion Criteria:
Patients currently taking rivaroxaban that have atrial fibrillation and require surgery or a procedure.
Patients currently taking dabigatran that have atrial fibrillation and require surgery or a procedure.
Patients currently taking apixaban that have atrial fibrillation and require surgery or a procedure.
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.
Time frame: Within 30 days of surgery or procedure
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.
Time frame: Within 30 days of surgery or procedure
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.
Time frame: 30 days or less after surgery or porcedure
Number of participants who die
Death: death due to any cause.
Time frame: 30 days or after surgery or procedure
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).
Time frame: 30 days or less after surgery
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.
Time frame: 30 days or less after surgery or procedure
Dilute TT test-Laboratory blood test of NOAC levels
• DOAC levels will be measured by the dilute TT test expressed in ng/mL.
Time frame: Day of Surgery
Anti-Xa test for NOAC level
DOAC levels as measured by an anti-Xa tests, expressed in ng/mL.
Time frame: Day of surgery
INR Laboratory Test
• The INR will be done to compare these tests with novel oral anticoagulant specialized Anti-Xa tests
Time frame: Day of surgery
PT Laboratory test
PT will be measured to compare these tests with novel oral anticoagulant specialized Anti-Xa tests
Time frame: Day of surgery
aPTT Laboratory test
To compare these tests with novel oral anticoagulant specialized Anti-Xa tests
Time frame: Day of Surgery
TT Laboratory test
To compare these tests with novel oral anticoagulant specialized Anti-Xa tests
Time frame: Day of surgery
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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