Perioperative Anticoagulant Use for Surgery Evaluation -Virtual Visit (PAUSE-Virtual)
NCT ID: NCT06844227
Last Updated: 2025-03-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
1780 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-12-01
Study Completion Date
2026-12-31
Brief Summary
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The purpose of the PAUSE-Virtual Study is to show that by changing pre-surgery visits with patients taking a blood thinner (direct oral anticoagulant (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) when the participant requires elective surgery, using a standard, in-person proven approach, to a virtual visit, either telephone or video conference, is as safe. Patients who are receiving a blood thinner for the medical condition known as atrial fibrillation (AF) and require an elective surgery/procedure, is common. These patients have to stop taking their blood thinner for a certain time before the procedure to reduce serious complications of stroke or bleeding. For doctors who help manage these patients before a procedure, appointments have been traditionally done in-person. Patients receive instructions about when to stop and restart their blood thinners and taught how to self-administrator a short acting blood thinner (heparin) if needed. The COVID pandemic changed the way these appointments were done, making it important to contact these patients without them having to come to the hospital for an in person visit. Virtual patient care, by telephone or video conference, to communicate to patients about when to start and restart their blood thinner was necessary. This study wants to show that this virtual method of instruction, using a standardized plan of managing patient care, is easy, acceptable to patients and as safe when compared to an in-person meeting. Such instruction would also be cost-efficient standard post-pandemic. Prior work has shown that both a standard care of patients who are receiving blood thinners and a point-of-care decision "app", available through Thrombosis Canada (www.thrombosiscanada.ca) website, have been trusted during this virtual visit successfully. The investigator will show, by following up at 30 days, that this standardized management plan is safe and can be done virtually, with a low risk of stroke and major bleeding.
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Detailed Description
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The Clinical Problem: The management of patients who are taking warfarin or a direct oral anticoagulant (DOAC) and need an elective surgery/procedure is a common and important clinical problem: (i) \~200,000 patients/yr are assessed in Canada for such management and this will increase due to an ageing population and an increase in anticoagulant use; and (ii) if anticoagulants are not managed carefully, with evidence-based protocols, patients can be exposed to an increased risk for disabling stroke if anticoagulant interruption is too long or life-threatening bleeding if interruption is too short.
The Healthcare Delivery Problem: Perioperative management of anticoagulant therapy has been traditionally done in an in-person setting where patients receive instructions about when to stop and restart anticoagulants and, if needed, to receive teaching to self-administer heparin bridging. The COVID pandemic has upended this healthcare delivery model, necessitating virtual management by phone/video. Virtual patient care to manage perioperative anticoagulation has the potential to be an efficient and patient-friendly standard post-pandemic. However, to attain this objective, it must be reliably shown that virtually-administered, standardized, perioperative anticoagulation management is: (i) safe, with acceptably low rates of stroke and bleeding; (ii) easy to apply in practice; and (iii) acceptable to patients.
The foundation for this study is based on prior work by the investigator: (i) The investigator has led multicenter clinical trials (BRIDGE, PAUSE) that provide benchmarks for safe perioperative management of patients who are receiving warfarin or a DOAC; (ii) the management protocols from these trials were incorporated into a clinical decision tool that is available (cost-free) by Thrombosis Canada (www.thrombosiscanada.ca). This point-of-care app allows input of patient-specific information to manage individual patients with atrial fibrillation/flutter (AF) who are receiving warfarin or a DOAC and require an elective surgery/procedure. At the end of the assessment, a care-path summary is available as a PDF for clinicians and patients for downloading and printing.
The Opportunity: The pandemic has necessitated the adoption of virtual perioperative anticoagulant management but also has provided the opportunity to re-evaluate how such care can be safely delivered. Given that (i) perioperative anticoagulant interruption/resumption and heparin bridging protocols are standardized, and (ii) there is an easy-to-use, point-of-care, management app available, the investigator has a unique opportunity to apply evidence-informed protocols with user-friendly knowledge translation tools to assess the safety and acceptability to patients of virtual perioperative anticoagulant management.
The Solution: A prospective cohort study (non-RCT) assessing standardized virtual perioperative management in 2 cohorts of patients on warfarin or a DOAC who require an elective surgery/procedure.
Hypothesis \& Postulates: (i) the investigator hypothesizes that virtual perioperative management will be safe for patient care, with 30-day postoperative rates of stroke/systemic embolism (SSE) ≤0.5% and major bleeding (MB) ≤1.5%. With a sample size of 847 patients in Cohort 1 and in Cohort 2, the investigator will have 90% power at the 95% level of significance to reject the null hypothesis that the observed rates are ≥1.5% for SSE and ≥3% for MB in each cohort. (ii) The investigator postulates (a) that virtual management will be as safe as in matched historical control groups who received benchmark in-person management, (b) that virtual management will reduce healthcare costs and costs to patients, and (c) that patients will be satisfied with virtual management and will be willing to receive this methods of healthcare delivery post-pandemic.
Significance: PAUSE-Virtual will shift perioperative anticoagulant management from a resource-intensive in-person model to a patient-friendly virtual model, establishing a standard-of-care option for 200,000 patients/yr in Canada. The investigator is a leading group in perioperative anticoagulant management worldwide, having done the landmark BRIDGE1 and PAUSE2 trials. There is no other research group (that the investigator knows of) that will do this trial, and it will not be funded by industry (no commercial interest).
The Healthcare Delivery Problem: Perioperative management of anticoagulant therapy has been traditionally done in an in-person setting where patients receive instructions about when to stop and restart anticoagulants and, if needed, to receive teaching to self-administer heparin bridging. The COVID pandemic has upended this healthcare delivery model, necessitating virtual management by phone/video. Virtual patient care to manage perioperative anticoagulation has the potential to be an efficient and patient-friendly standard post-pandemic. However, to attain this objective, it must be reliably shown that virtually-administered, standardized, perioperative anticoagulation management is: (i) safe, with acceptably low rates of stroke and bleeding; (ii) easy to apply in practice; and (iii) acceptable to patients.
The foundation for this study is based on prior work by the investigator: (i) The investigator has led multicenter clinical trials (BRIDGE, PAUSE) that provide benchmarks for safe perioperative management of patients who are receiving warfarin or a DOAC; (ii) the management protocols from these trials were incorporated into a clinical decision tool that is available (cost-free) by Thrombosis Canada (www.thrombosiscanada.ca). This point-of-care app allows input of patient-specific information to manage individual patients with atrial fibrillation/flutter (AF) who are receiving warfarin or a DOAC and require an elective surgery/procedure. At the end of the assessment, a care-path summary is available as a PDF for clinicians and patients for downloading and printing.
The Opportunity: The pandemic has necessitated the adoption of virtual perioperative anticoagulant management but also has provided the opportunity to re-evaluate how such care can be safely delivered. Given that (i) perioperative anticoagulant interruption/resumption and heparin bridging protocols are standardized, and (ii) there is an easy-to-use, point-of-care, management app available, the investigator has a unique opportunity to apply evidence-informed protocols with user-friendly knowledge translation tools to assess the safety and acceptability to patients of virtual perioperative anticoagulant management.
The Solution: A prospective cohort study (non-RCT) assessing standardized virtual perioperative management in 2 cohorts of patients on warfarin or a DOAC who require an elective surgery/procedure.
Hypothesis \& Postulates: (i) the investigator hypothesizes that virtual perioperative management will be safe for patient care, with 30-day postoperative rates of stroke/systemic embolism (SSE) ≤0.5% and major bleeding (MB) ≤1.5%. With a sample size of 847 patients in Cohort 1 and in Cohort 2, the investigator will have 90% power at the 95% level of significance to reject the null hypothesis that the observed rates are ≥1.5% for SSE and ≥3% for MB in each cohort. (ii) The investigator postulates (a) that virtual management will be as safe as in matched historical control groups who received benchmark in-person management, (b) that virtual management will reduce healthcare costs and costs to patients, and (c) that patients will be satisfied with virtual management and will be willing to receive this methods of healthcare delivery post-pandemic.
Significance: PAUSE-Virtual will shift perioperative anticoagulant management from a resource-intensive in-person model to a patient-friendly virtual model, establishing a standard-of-care option for 200,000 patients/yr in Canada. The investigator is a leading group in perioperative anticoagulant management worldwide, having done the landmark BRIDGE1 and PAUSE2 trials. There is no other research group (that the investigator knows of) that will do this trial, and it will not be funded by industry (no commercial interest).
Conditions
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Atrial Fibrillation (AF)
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Cohort 1: warfarin-treated patients
Cohort 1: warfarin-treated patients with AF who receive virtual perioperative management
No interventions assigned to this group
Cohort 2: DOAC-treated patients
Cohort 2: DOAC-treated patients with AF who receive virtual perioperative management.
Using this design, the investigator aims to show in Cohorts 1 and 2 that virtual management is non-inferior to benchmark in-person management, defined by 30-day postoperative rates of SSE ≤0.5% (with 95% confidence to exclude 1.5% rate) and MB ≤1.5% (with 95% confidence to exclude 3% rate).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 18 years of age or older with AF/flutter (chronic, persistent, paroxysmal) that requires anticoagulation
* Receiving warfarin, with a target international normalized ratio (INR) range of 2.0-3.0, or a DOAC, comprising one of the following regimens: apixaban, 2.5 mg or 5 mg bid; edoxaban, 30 mg or 60 mg daily; dabigatran, 110 mg or 150 mg bid; or rivaroxaban, 15 mg or 20 mg daily
* Require an elective (planned, non-urgent) surgery or invasive medical or surgical procedure
* Receiving warfarin, with a target international normalized ratio (INR) range of 2.0-3.0, or a DOAC, comprising one of the following regimens: apixaban, 2.5 mg or 5 mg bid; edoxaban, 30 mg or 60 mg daily; dabigatran, 110 mg or 150 mg bid; or rivaroxaban, 15 mg or 20 mg daily
* Require an elective (planned, non-urgent) surgery or invasive medical or surgical procedure
Exclusion Criteria
* Indication for anticoagulation is not AF/flutter (e.g., mechanical heart valve, VTE, other)
* Non-standard anticoagulant regimen used (e.g., warfarin INR 3-4, rivaroxaban 2.5 mg bid)
* In DOAC users only: creatinine clearance \<25 mL/min (that preclude DOAC use)
* Cognitive impairment or psychiatric illness (that precludes reliable contact during follow-up)
* Unable or unwilling to provide consent for virtual care (in-person care will be provided)
* Previous participation in this study for an elective surgery/procedure
* Non-standard anticoagulant regimen used (e.g., warfarin INR 3-4, rivaroxaban 2.5 mg bid)
* In DOAC users only: creatinine clearance \<25 mL/min (that preclude DOAC use)
* Cognitive impairment or psychiatric illness (that precludes reliable contact during follow-up)
* Unable or unwilling to provide consent for virtual care (in-person care will be provided)
* Previous participation in this study for an elective surgery/procedure
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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James D Douketis, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University/St. Joseph's Healthcare
Locations
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Endeavor Health - Northshore
Evanston, Illinois, United States
Site Status
RECRUITING
Henry Ford
Detroit, Michigan, United States
Site Status
RECRUITING
Northwell Health
Great Neck, New York, United States
Site Status
RECRUITING
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Site Status
RECRUITING
Hamilton General Hospital
Hamilton, Ontario, Canada
Site Status
RECRUITING
St. Joesph's Healthcare
Hamilton, Ontario, Canada
Site Status
RECRUITING
Juravinski
Hamilton, Ontario, Canada
Site Status
RECRUITING
The Ottawa Hospital
Ottawa, Ontario, Canada
Site Status
RECRUITING
Larissa University Hospital
Larissa, Larisa, Greece
Site Status
RECRUITING
Countries
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United States
Canada
Greece
Central Contacts
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Facility Contacts
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References
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Shaw JR, Zhang T, Le Gal G, Douketis J, Carrier M. Perioperative interruption of direct oral anticoagulants and vitamin K antagonists in patients with atrial fibrillation: A comparative analysis. Res Pract Thromb Haemost. 2020 Jan 20;4(1):131-140. doi: 10.1002/rth2.12285. eCollection 2020 Jan.
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Andrade JG, Aguilar M, Atzema C, Bell A, Cairns JA, Cheung CC, Cox JL, Dorian P, Gladstone DJ, Healey JS, Khairy P, Leblanc K, McMurtry MS, Mitchell LB, Nair GM, Nattel S, Parkash R, Pilote L, Sandhu RK, Sarrazin JF, Sharma M, Skanes AC, Talajic M, Tsang TSM, Verma A, Verma S, Whitlock R, Wyse DG, Macle L; Members of the Secondary Panel. The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation. Can J Cardiol. 2020 Dec;36(12):1847-1948. doi: 10.1016/j.cjca.2020.09.001. Epub 2020 Oct 22.
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Pancholy SB, Sharma PS, Pancholy DS, Patel TM, Callans DJ, Marchlinski FE. Meta-analysis of gender differences in residual stroke risk and major bleeding in patients with nonvalvular atrial fibrillation treated with oral anticoagulants. Am J Cardiol. 2014 Feb 1;113(3):485-90. doi: 10.1016/j.amjcard.2013.10.035. Epub 2013 Nov 11.
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McAlister FA, Garrison S, Kosowan L, Ezekowitz JA, Singer A. Use of Direct Oral Anticoagulants in Canadian Primary Care Practice 2010-2015: A Cohort Study From the Canadian Primary Care Sentinel Surveillance Network. J Am Heart Assoc. 2018 Jan 26;7(3):e007603. doi: 10.1161/JAHA.117.007603.
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Czeisler ME, Marynak K, Clarke KEN, Salah Z, Shakya I, Thierry JM, Ali N, McMillan H, Wiley JF, Weaver MD, Czeisler CA, Rajaratnam SMW, Howard ME. Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020 Sep 11;69(36):1250-1257. doi: 10.15585/mmwr.mm6936a4.
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Sackett DL. Bias in analytic research. J Chronic Dis. 1979;32(1-2):51-63. doi: 10.1016/0021-9681(79)90012-2. No abstract available.
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Spyropoulos AC, Myrka A, Triller DM, Ragan S, York C, King JM, Lee TK. Uptake and Utilization of the Management of Anticoagulation in the Periprocedural Period App: Longitudinal Analysis. JMIR Mhealth Uhealth. 2018 Dec 21;6(12):e11090. doi: 10.2196/11090.
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Spyropoulos AC, Giannis D, Cohen J, John S, Myrka A, Inlall D, Qiu M, Akgul S, Hyman RJ, Wang JJ. Implementation of the Management of Anticoagulation in the Periprocedural Period App Into an Electronic Health Record: A Prospective Cohort Study. Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620925910. doi: 10.1177/1076029620925910.
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BACKGROUND
Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC; ROCKET AF Investigators. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014 May 6;129(18):1850-9. doi: 10.1161/CIRCULATIONAHA.113.005754. Epub 2014 Feb 19.
Reference Type
BACKGROUND
Spyropoulos AC, Douketis JD. Guidelines for antithrombotic therapy: periprocedural management of antithrombotic therapy and use of bridging anticoagulation. Int Angiol. 2008 Aug;27(4):333-43. No abstract available.
Reference Type
BACKGROUND
Spyropoulos AC, Albaladejo P, Godier A, Greinacher A, Hron G, Levy JH, Samama CM, Douketis JD. Periprocedural antiplatelet therapy: recommendations for standardized reporting in patients on antiplatelet therapy: communication from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1593-6. doi: 10.1111/jth.12282. No abstract available.
Reference Type
BACKGROUND
Spyropoulos AC, Brohi K, Caprini J, Samama CM, Siegal D, Tafur A, Verhamme P, Douketis JD; SSC Subcommittee on Perioperative and Critical Care Thrombosis and Haemostasis of the International Society on Thrombosis and Haemostasis. Scientific and Standardization Committee Communication: Guidance document on the periprocedural management of patients on chronic oral anticoagulant therapy: Recommendations for standardized reporting of procedural/surgical bleed risk and patient-specific thromboembolic risk. J Thromb Haemost. 2019 Nov;17(11):1966-1972. doi: 10.1111/jth.14598. Epub 2019 Aug 22. No abstract available.
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BACKGROUND
Spyropoulos AC, Douketis JD, Gerotziafas G, Kaatz S, Ortel TL, Schulman S; Subcommittee on Control of Anticoagulation of the SSC of the ISTH. Periprocedural antithrombotic and bridging therapy: recommendations for standardized reporting in patients with arterial indications for chronic oral anticoagulant therapy. J Thromb Haemost. 2012 Apr;10(4):692-4. doi: 10.1111/j.1538-7836.2012.04630.x. No abstract available.
Reference Type
BACKGROUND
Douketis JD, Berger PB, Dunn AS, Jaffer AK, Spyropoulos AC, Becker RC, Ansell J. The perioperative management of antithrombotic therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):299S-339S. doi: 10.1378/chest.08-0675.
Reference Type
BACKGROUND
Clark NP, Douketis JD, Hasselblad V, Schulman S, Kindzelski AL, Ortel TL; BRIDGE Investigators. Predictors of perioperative major bleeding in patients who interrupt warfarin for an elective surgery or procedure: Analysis of the BRIDGE trial. Am Heart J. 2018 Jan;195:108-114. doi: 10.1016/j.ahj.2017.09.015. Epub 2017 Sep 21.
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BACKGROUND
Kaatz S, Douketis JD, Zhou H, Gage BF, White RH. Risk of stroke after surgery in patients with and without chronic atrial fibrillation. J Thromb Haemost. 2010 May;8(5):884-90. doi: 10.1111/j.1538-7836.2010.03781.x. Epub 2010 Jan 24.
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BACKGROUND
MacDougall K, Douketis JD, Li N, Clark NP, Tafur A, D'Astous J, Duncan J, Schulman S, Spyropoulos AC. Effect of Direct Oral Anticoagulant, Patient, and Surgery Characteristics on Clinical Outcomes in the Perioperative Anticoagulation Use for Surgery Evaluation Study. TH Open. 2020 Sep 23;4(3):e255-e262. doi: 10.1055/s-0040-1716512. eCollection 2020 Jul.
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BACKGROUND
Tafur AJ, Clark NP, Spyropoulos AC, Li N, Kaplovitch E, MacDougall K, Schulman S, Caprini JA, Douketis J. Predictors of Bleeding in the Perioperative Anticoagulant Use for Surgery Evaluation Study. J Am Heart Assoc. 2020 Oct 20;9(19):e017316. doi: 10.1161/JAHA.120.017316. Epub 2020 Sep 24.
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BACKGROUND
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.
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BACKGROUND
Douketis JD, Syed S, Schulman S. Periprocedural Management of Direct Oral Anticoagulants: Comment on the 2015 American Society of Regional Anesthesia and Pain Medicine Guidelines. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):127-9. doi: 10.1097/AAP.0000000000000360. No abstract available.
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BACKGROUND
Kim PY, Di Giuseppantonio LR, Wu C, Douketis JD, Gross PL. An assay to measure levels of factor Xa inhibitors in blood and plasma. J Thromb Haemost. 2019 Jul;17(7):1153-1159. doi: 10.1111/jth.14451. Epub 2019 May 10.
Reference Type
BACKGROUND
Dube C, Douketis JD, Moffat KA, Schulman S, Blais N. Basic coagulation tests as surrogates of dabigatran levels in a pre-operative setting: Analysis of five activated partial thromboplastin time reagents and thrombin time. Thromb Res. 2018 Nov;171:62-67. doi: 10.1016/j.thromres.2018.09.051. Epub 2018 Sep 19.
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BACKGROUND
Douketis J, Schulman S, Syed S. Reply to Dr Lessire et al. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):788. doi: 10.1097/AAP.0000000000000478. No abstract available.
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BACKGROUND
Douketis JD, Johnson JA, Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch Intern Med. 2004 Jun 28;164(12):1319-26. doi: 10.1001/archinte.164.12.1319.
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BACKGROUND
Schulman S, Carrier M, Lee AY, Shivakumar S, Blostein M, Spencer FA, Solymoss S, Barty R, Wang G, Heddle N, Douketis JD; Periop Dabigatran Study Group. Perioperative Management of Dabigatran: A Prospective Cohort Study. Circulation. 2015 Jul 21;132(3):167-73. doi: 10.1161/CIRCULATIONAHA.115.015688. Epub 2015 May 12.
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BACKGROUND
Douketis JD, Murphy SA, Antman EM, Grip LT, Mercuri MF, Ruff CT, Weitz JI, Braunwald E, Giugliano RP. Peri-operative Adverse Outcomes in Patients with Atrial Fibrillation Taking Warfarin or Edoxaban: Analysis of the ENGAGE AF-TIMI 48 Trial. Thromb Haemost. 2018 Jun;118(6):1001-1008. doi: 10.1055/s-0038-1645856. Epub 2018 May 3.
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Douketis J, Wang J, Cuddy K, Wagler M, Kinnon K, Crowther M. The safety of co-administered continuous epidural analgesia and low-molecular-weight heparin after major orthopedic surgery: assessment of a standardized patient management protocol. Thromb Haemost. 2006 Sep;96(3):387-9. doi: 10.1160/TH06-06-0303. No abstract available.
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Douketis JD, Wang G, Chan N, Eikelboom JW, Syed S, Barty R, Moffat KA, Spencer FA, Blostein M, Schulman S. Effect of standardized perioperative dabigatran interruption on the residual anticoagulation effect at the time of surgery or procedure. J Thromb Haemost. 2016 Jan;14(1):89-97. doi: 10.1111/jth.13178. Epub 2016 Jan 4.
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Douketis JD, Healey JS, Brueckmann M, Fraessdorf M, Spyropoulos AC, Wallentin L, Oldgren J, Reilly P, Ezekowitz MD, Connolly SJ, Yusuf S, Eikelboom JW. Urgent surgery or procedures in patients taking dabigatran or warfarin: Analysis of perioperative outcomes from the RE-LY trial. Thromb Res. 2016 Mar;139:77-81. doi: 10.1016/j.thromres.2016.01.004. Epub 2016 Jan 9.
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Douketis JD, Healey JS, Brueckmann M, Eikelboom JW, Ezekowitz MD, Fraessdorf M, Noack H, Oldgren J, Reilly P, Spyropoulos AC, Wallentin L, Connolly SJ. Perioperative bridging anticoagulation during dabigatran or warfarin interruption among patients who had an elective surgery or procedure. Substudy of the RE-LY trial. Thromb Haemost. 2015 Mar;113(3):625-32. doi: 10.1160/TH14-04-0305. Epub 2014 Dec 4.
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Spyropoulos AC, Turpie AG, Dunn AS, Kaatz S, Douketis J, Jacobson A, Petersen H; REGIMEN Investigators. Perioperative bridging therapy with unfractionated heparin or low-molecular-weight heparin in patients with mechanical prosthetic heart valves on long-term oral anticoagulants (from the REGIMEN Registry). Am J Cardiol. 2008 Oct 1;102(7):883-9. doi: 10.1016/j.amjcard.2008.05.042. Epub 2008 Jul 31.
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Bell BR, Spyropoulos AC, Douketis JD. Perioperative Management of the Direct Oral Anticoagulants: A Case-Based Review. Hematol Oncol Clin North Am. 2016 Oct;30(5):1073-84. doi: 10.1016/j.hoc.2016.05.005.
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Shaw JR, Kaplovitch E, Douketis J. Periprocedural Management of Oral Anticoagulation. Med Clin North Am. 2020 Jul;104(4):709-726. doi: 10.1016/j.mcna.2020.02.005. Epub 2020 May 12.
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Douketis JD. Perioperative management of warfarin therapy: to bridge or not to bridge, that is the question. Mayo Clin Proc. 2008 Jun;83(6):628-9. doi: 10.4065/83.6.628. No abstract available.
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Spyropoulos AC. Perioperative bridging therapy for the at-risk patient on chronic anticoagulation. Dis Mon. 2005 Feb-Mar;51(2-3):183-93. doi: 10.1016/j.disamonth.2005.03.014. No abstract available.
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Spyropoulos AC. Bridging of oral anticoagulation therapy for invasive procedures. Curr Hematol Rep. 2005 Sep;4(5):405-13.
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Douketis JD, Crowther MA, Cherian SS, Kearon CB. Physician preferences for perioperative anticoagulation in patients with a mechanical heart valve who are undergoing elective noncardiac surgery. Chest. 1999 Nov;116(5):1240-6. doi: 10.1378/chest.116.5.1240.
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Douketis JD, Crowther MA, Cherian SS. Perioperative anticoagulation in patients with chronic atrial fibrillation who are undergoing elective surgery: results of a physician survey. Can J Cardiol. 2000 Mar;16(3):326-30.
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Douketis JD. Pharmacologic properties of the new oral anticoagulants: a clinician-oriented review with a focus on perioperative management. Curr Pharm Des. 2010;16(31):3436-41. doi: 10.2174/138161210793563338.
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Douketis J, Bell AD, Eikelboom J, Liew A. Approach to the new oral anticoagulants in family practice: part 2: addressing frequently asked questions. Can Fam Physician. 2014 Nov;60(11):997-1001.
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Douketis JD. Perioperative anticoagulation management in patients who are receiving oral anticoagulant therapy: a practical guide for clinicians. Thromb Res. 2002 Oct 1;108(1):3-13. doi: 10.1016/s0049-3848(02)00387-0.
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Douketis J, Cervi A. Managing patients who are receiving warfarin or a direct oral anticoagulant and need an elective surgery or procedure. Blood Adv. 2019 Jun 25;3(12):1925. doi: 10.1182/bloodadvances.2019000171. No abstract available.
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Jamula E, Lloyd NS, Schwalm JD, Airaksinen KE, Douketis JD. Safety of uninterrupted anticoagulation in patients requiring elective coronary angiography with or without percutaneous coronary intervention: a systematic review and metaanalysis. Chest. 2010 Oct;138(4):840-7. doi: 10.1378/chest.09-2603. Epub 2010 Apr 30.
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Jamula E, Anderson J, Douketis JD. Safety of continuing warfarin therapy during cataract surgery: a systematic review and meta-analysis. Thromb Res. 2009 Jul;124(3):292-9. doi: 10.1016/j.thromres.2009.01.007. Epub 2009 Feb 23.
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Shaw JR, Woodfine JD, Douketis J, Schulman S, Carrier M. Perioperative interruption of direct oral anticoagulants in patients with atrial fibrillation: A systematic review and meta-analysis. Res Pract Thromb Haemost. 2018 Feb 16;2(2):282-290. doi: 10.1002/rth2.12076. eCollection 2018 Apr.
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Siegal D, Yudin J, Kaatz S, Douketis JD, Lim W, Spyropoulos AC. Periprocedural heparin bridging in patients receiving vitamin K antagonists: systematic review and meta-analysis of bleeding and thromboembolic rates. Circulation. 2012 Sep 25;126(13):1630-9. doi: 10.1161/CIRCULATIONAHA.112.105221. Epub 2012 Aug 21.
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Asiri A, AlBishi S, AlMadani W, ElMetwally A, Househ M. The Use of Telemedicine in Surgical Care: a Systematic Review. Acta Inform Med. 2018 Oct;26(3):201-206. doi: 10.5455/aim.2018.26.201-206.
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Brundisini F, Giacomini M, DeJean D, Vanstone M, Winsor S, Smith A. Chronic disease patients' experiences with accessing health care in rural and remote areas: a systematic review and qualitative meta-synthesis. Ont Health Technol Assess Ser. 2013 Sep 1;13(15):1-33. eCollection 2013.
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Cevik M, Bamford CGG, Ho A. COVID-19 pandemic-a focused review for clinicians. Clin Microbiol Infect. 2020 Jul;26(7):842-847. doi: 10.1016/j.cmi.2020.04.023. Epub 2020 Apr 25.
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COVIDSurg Collaborative. Global guidance for surgical care during the COVID-19 pandemic. Br J Surg. 2020 Aug;107(9):1097-1103. doi: 10.1002/bjs.11646. Epub 2020 Apr 15.
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Holman N, Knighton P, Kar P, O'Keefe J, Curley M, Weaver A, Barron E, Bakhai C, Khunti K, Wareham NJ, Sattar N, Young B, Valabhji J. Risk factors for COVID-19-related mortality in people with type 1 and type 2 diabetes in England: a population-based cohort study. Lancet Diabetes Endocrinol. 2020 Oct;8(10):823-833. doi: 10.1016/S2213-8587(20)30271-0. Epub 2020 Aug 13.
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Mihalj M, Carrel T, Gregoric ID, Andereggen L, Zinn PO, Doll D, Stueber F, Gabriel RA, Urman RD, Luedi MM. Telemedicine for preoperative assessment during a COVID-19 pandemic: Recommendations for clinical care. Best Pract Res Clin Anaesthesiol. 2020 Jun;34(2):345-351. doi: 10.1016/j.bpa.2020.05.001. Epub 2020 May 14.
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Miner H, Fatehi A, Ring D, Reichenberg JS. Clinician Telemedicine Perceptions During the COVID-19 Pandemic. Telemed J E Health. 2021 May;27(5):508-512. doi: 10.1089/tmj.2020.0295. Epub 2020 Sep 18.
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Douketis JD, Syed S, Li N, Narouze S, Radwi M, Duncan J, Schulman S, Spyropoulos AC. A physician survey of perioperative neuraxial anesthesia management in patients on a direct oral anticoagulant. Res Pract Thromb Haemost. 2020 Dec 16;5(1):159-167. doi: 10.1002/rth2.12430. eCollection 2021 Jan.
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Spencer NH, Sardo LA, Cordell JP, Douketis JD. Structure and function of a perioperative anticoagulation management clinic. Thromb Res. 2019 Oct;182:167-174. doi: 10.1016/j.thromres.2019.08.007. Epub 2019 Aug 23.
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Spyropoulos AC, Douketis JD. How I treat anticoagulated patients undergoing an elective procedure or surgery. Blood. 2012 Oct 11;120(15):2954-62. doi: 10.1182/blood-2012-06-415943. Epub 2012 Aug 28.
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Spyropoulos AC, Bauersachs RM, Omran H, Cohen M. Periprocedural bridging therapy in patients receiving chronic oral anticoagulation therapy. Curr Med Res Opin. 2006 Jun;22(6):1109-22. doi: 10.1185/030079906X104858.
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Douketis JD. Perioperative management of patients who are receiving warfarin therapy: an evidence-based and practical approach. Blood. 2011 May 12;117(19):5044-9. doi: 10.1182/blood-2011-02-329979. Epub 2011 Mar 17. No abstract available.
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Douketis JD. Perioperative management of patients receiving anticoagulant or antiplatelet therapy: a clinician-oriented and practical approach. Hosp Pract (1995). 2011 Oct;39(4):41-54. doi: 10.3810/hp.2011.10.921.
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Steinberg BA, Hellkamp AS, Lokhnygina Y, Halperin JL, Breithardt G, Passman R, Hankey GJ, Patel MR, Becker RC, Singer DE, Hacke W, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Piccini JP; ROCKET AF Steering Committee and Investigators. Use and outcomes of antiarrhythmic therapy in patients with atrial fibrillation receiving oral anticoagulation: results from the ROCKET AF trial. Heart Rhythm. 2014 Jun;11(6):925-32. doi: 10.1016/j.hrthm.2014.03.006. Epub 2014 May 13.
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Broderick JP, Bonomo JB, Kissela BM, Khoury JC, Moomaw CJ, Alwell K, Woo D, Flaherty ML, Khatri P, Adeoye O, Ferioli S, Kleindorfer DO. Withdrawal of antithrombotic agents and its impact on ischemic stroke occurrence. Stroke. 2011 Sep;42(9):2509-14. doi: 10.1161/STROKEAHA.110.611905. Epub 2011 Jun 30.
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Spyropoulos AC, Al-Badri A, Sherwood MW, Douketis JD. Periprocedural management of patients receiving a vitamin K antagonist or a direct oral anticoagulant requiring an elective procedure or surgery. J Thromb Haemost. 2016 May;14(5):875-85. doi: 10.1111/jth.13305. Epub 2016 Apr 7.
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Barnes GD, Lucas E, Alexander GC, Goldberger ZD. National Trends in Ambulatory Oral Anticoagulant Use. Am J Med. 2015 Dec;128(12):1300-5.e2. doi: 10.1016/j.amjmed.2015.05.044. Epub 2015 Jul 2.
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Weitz JI, Semchuk W, Turpie AG, Fisher WD, Kong C, Ciaccia A, Cairns JA. Trends in Prescribing Oral Anticoagulants in Canada, 2008-2014. Clin Ther. 2015 Nov 1;37(11):2506-2514.e4. doi: 10.1016/j.clinthera.2015.09.008. Epub 2015 Oct 16.
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Gao L, Tadrous M, Knowles S, Mamdani M, Paterson JM, Juurlink D, Gomes T. Prior Authorization and Canadian Public Utilization of Direct-Acting Oral Anticoagulants. Healthc Policy. 2017 Nov;13(2):68-78. doi: 10.12927/hcpol.2017.25321.
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Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, Themeles E, Heidbuchel H, Avezum A, Reilly P, Connolly SJ, Yusuf S, Ezekowitz M; RE-LY Investigators. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation. 2012 Jul 17;126(3):343-8. doi: 10.1161/CIRCULATIONAHA.111.090464. Epub 2012 Jun 14.
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Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, Dunn AS, Kunz R. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e326S-e350S. doi: 10.1378/chest.11-2298.
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Proietti M, Laroche C, Opolski G, Maggioni AP, Boriani G, Lip GYH; AF Gen Pilot Investigators. 'Real-world' atrial fibrillation management in Europe: observations from the 2-year follow-up of the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase. Europace. 2017 May 1;19(5):722-733. doi: 10.1093/europace/euw112.
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Steinberg BA, Gao H, Shrader P, Pieper K, Thomas L, Camm AJ, Ezekowitz MD, Fonarow GC, Gersh BJ, Goldhaber S, Haas S, Hacke W, Kowey PR, Ansell J, Mahaffey KW, Naccarelli G, Reiffel JA, Turpie A, Verheugt F, Piccini JP, Kakkar A, Peterson ED, Fox KAA; GARFIELD-AF; ORBIT-AF Investigators. International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J. 2017 Dec;194:132-140. doi: 10.1016/j.ahj.2017.08.011. Epub 2017 Aug 24.
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Williams BA, Honushefsky AM, Berger PB. Temporal Trends in the Incidence, Prevalence, and Survival of Patients With Atrial Fibrillation From 2004 to 2016. Am J Cardiol. 2017 Dec 1;120(11):1961-1965. doi: 10.1016/j.amjcard.2017.08.014. Epub 2017 Aug 30.
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Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.
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Douketis JD, Spyropoulos AC, Duncan J, Carrier M, Le Gal G, Tafur AJ, Vanassche T, Verhamme P, Shivakumar S, Gross PL, Lee AYY, Yeo E, Solymoss S, Kassis J, Le Templier G, Kowalski S, Blostein M, Shah V, MacKay E, Wu C, Clark NP, Bates SM, Spencer FA, Arnaoutoglou E, Coppens M, Arnold DM, Caprini JA, Li N, Moffat KA, Syed S, Schulman S. Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant. JAMA Intern Med. 2019 Nov 1;179(11):1469-1478. doi: 10.1001/jamainternmed.2019.2431.
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Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.
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Related Links
Access external resources that provide additional context or updates about the study.
http://patientsafety.pa.gov/ADVISORIES/Pages/201806_DOACs.aspx
Valentine D GM, Grissinger M. . Valentine D, Gaunt MJ, Grissinger M. Identifying Patient Harm from Direct Oral Anticoagulants. Available from http://patientsafety.pa.gov/ADVISORIES/Pages/201806\_DOACs.aspx. 2020
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202104PJT-461879-CID-CEBA-5761
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PAUSE Virtual (CTO 3854)
Identifier Type: -
Identifier Source: org_study_id
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