Perioperative Anticoagulant Use for Surgery Evaluation Study (PAUSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02228798|
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : June 28, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||3135 participants|
|Official Title:||Perioperative Anticoagulant Use (Dabigatran, Rivaroxaban, or Apixaban) for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF).|
|Actual Study Start Date :||August 1, 2014|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
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 [ Time Frame: Within 30 days of surgery or procedure ]
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.
- Number of participants with Atrial Thromboembolism [ Time Frame: Within 30 days of surgery or procedure ]
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.
- Number of participants with Minor bleeding [ Time Frame: 30 days or less after surgery or porcedure ]• 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.
- Number of participants who die [ Time Frame: 30 days or after surgery or procedure ]Death: death due to any cause.
- Number of participants that have a Venous Thromboembolism (VTE) [ Time Frame: 30 days or less after surgery ]Venous thromboembolism (VTE): comprising symptomatic deep vein thrombosis and pulmonary embolism, confirmed by objective imaging studies (e.g., ultrasound, CT pulmonary angiogram).
- Number of participants who acquire Acute Coronary Syndrome [ Time Frame: 30 days or less after surgery or procedure ]• 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.
- Dilute TT test-Laboratory blood test of NOAC levels [ Time Frame: Day of Surgery ]• DOAC levels will be measured by the dilute TT test expressed in ng/mL.
- Anti-Xa test for NOAC level [ Time Frame: Day of surgery ]DOAC levels as measured by an anti-Xa tests, expressed in ng/mL.
- INR Laboratory Test [ Time Frame: Day of surgery ]• The INR will be done to compare these tests with novel oral anticoagulant specialized Anti-Xa tests
- PT Laboratory test [ Time Frame: Day of surgery ]PT will be measured to compare these tests with novel oral anticoagulant specialized Anti-Xa tests
- aPTT Laboratory test [ Time Frame: Day of Surgery ]To compare these tests with novel oral anticoagulant specialized Anti-Xa tests
- TT Laboratory test [ Time Frame: Day of surgery ]To compare these tests with novel oral anticoagulant specialized Anti-Xa tests
Biospecimen Retention: Samples Without DNA
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
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.
- Age 18 years or older
- Receiving a DOAC (dabigatran or rivaroxaban or apixaban) for Atrial Fibrillation
- Ability to assess patient at lease one day prior to DOAC discontinuation
- 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
- Cognitive impairment or psychiatric illness that precludes collection of followup data
- Inability or unwillingness to provide informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228798
|Principal Investigator:||James Douketis, MD||McMaster University/St. Joseph's Healthcare|
|Responsible Party:||James Douketis, Dr. James Douketis-Principal Investigator, McMaster University|
|Other Study ID Numbers:||
CIHR313156 HSFG-14-0006163 ( Other Grant/Funding Number: CIHR, HSF )
|First Posted:||August 29, 2014 Key Record Dates|
|Last Update Posted:||June 28, 2019|
|Last Verified:||June 2019|