Atrial FibrillationPAUSENCT02228798
Perioperative Anticoagulant Use for Surgery Evaluation Study
An observational study of Atrial Fibrillation, run by McMaster University at 21 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 3,135 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 1 Aug 2014to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Canada15 sites
University of Alberta
Edmonton, Alberta
QEII Hospital
Halifax, Nova Scotia
Hamilton General Hospital
Hamilton, Ontario
Juravinski Hospital
Hamilton, Ontario
McMaster University Medical Centre
Hamilton, Ontario
St. Joseph's Healthcare
Hamilton, Ontario
Maisonneuve-Rosemont
Montreal, Quebec
Montreal General Hospital
Montreal, Quebec
Montreal Jewish General Hospital
Montreal, Quebec
St. Mary's Hospital
Montreal, Quebec
The Ottawa Hospital
Ottawa, Ontario
North York General
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
University of Manitoba
Winnipeg, Ontario
United States3 sites
Department of Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA
Aurora, Colorado
Henry Ford Health System
Detroit, Michigan, 48202
NorthShore University HealthSystem
Evanston, Illinois, 60201
Belgium1 site
Department of Cardiovascular Sciences, University of Leuven
Leuven
Netherlands1 site
Department of Vascular Medicine, Amsterdam Cardiovascular Sciences
Amsterdam
About this study
Official title: Perioperative Anticoagulant Use (Dabigatran, Rivaroxaban, or Apixaban) for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF).
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation
- Keywords
- anticoagulant, atrial fibrillation, surgery, oral anticoagulant, discontinue, DOAC, NOAC, blood thinner, interruption
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Patients currently taking rivaroxaban that have atrial fibrillation and require surgery or a procedure. | |
| Dabigatran | Patients currently taking dabigatran that have atrial fibrillation and require surgery or a procedure. | |
| Apixaban | Patients currently taking apixaban that have atrial fibrillation and require surgery or a procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 30 days of surgery or procedure
Secondary outcomes (4)
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.
Measured: 30 days or less after surgery or porcedure
Number of participants who die
Death: death due to any cause.
Measured: 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).
Measured: 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.
Measured: 30 days or less after surgery or procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study start1 Aug 2014
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, James Douketis, McMaster University
- Investigators
- James Douketis, MD, Principal investigator, McMaster University/St. Joseph's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228798
- Sponsor's protocol ID
- CIHR-PAUSE-2014
- Other IDs
- CIHR313156 HSFG-14-0006163
- Acronym
- PAUSE
- Status last verified
- Jun 2019
- First submitted
- 25 Aug 2014
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shaw JR, Li N, Vanassche T, Coppens M, Spyropoulos AC, Syed S, Radwi M, Duncan J, Schulman S, Douketis JD. Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure. Blood Adv. 2020 Aug 11;4(15):3520-3527. doi: 10.1182/bloodadvances.2020002335.
PubMed 32756938
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Anticoagulant Use (Dabigatran, Rivaroxaban, or Apixaban) for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF).
- ClinicalTrials.gov ID
- NCT02228798
- Acronym / sponsor ID
- PAUSE / CIHR-PAUSE-2014
- Conditions
- Atrial Fibrillation
- Keywords
- anticoagulant, atrial fibrillation, surgery, oral anticoagulant, discontinue, DOAC, NOAC, blood thinner
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,135 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | – | –Patients currently taking rivaroxaban that have atrial fibrillation and require surgery or a procedure. |
| Dabigatran | – | –Patients currently taking dabigatran that have atrial fibrillation and require surgery or a procedure. |
| Apixaban | – | –Patients currently taking apixaban that have atrial fibrillation and require surgery or a procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Number of participants with Minor bleeding
Time frame: 30 days or less after surgery or porcedure
Number of participants who die
Time frame: 30 days or after surgery or procedure
Number of participants that have a Venous Thromboembolism (VTE)
Time frame: 30 days or less after surgery
Number of participants who acquire Acute Coronary Syndrome
Time frame: 30 days or less after surgery or procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Derived from this study: PubMed 32756938Shaw JR, Li N, Vanassche T, Coppens M, Spyropoulos AC, Syed S, Radwi M, Duncan J, Schulman S, Douketis JD. Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure. Blood Adv. 2020 Aug 11;4(15):3520-3527. doi: 10.1182/bloodadvances.2020002335.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Douketis, MD principal investigator
McMaster University/St. Joseph's Healthcare
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by McMaster University at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Canada, United States, Belgium, Greece, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Major Bleeds (time frame: Within 30 days of surgery or procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.