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Completed

NCT Number: NCT02228798

Perioperative Anticoagulant Use for Surgery Evaluation Study

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Number of participants who die

    Time frame: 30 days or after surgery or procedure

    Death: death due to any cause.

  3. 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).

  4. 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.

Other outcomes

  1. 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.

  2. Anti-Xa test for NOAC level

    Time frame: Day of surgery

    DOAC levels as measured by an anti-Xa tests, expressed in ng/mL.

  3. 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

  4. PT Laboratory test

    Time frame: Day of surgery

    PT will be measured to compare these tests with novel oral anticoagulant specialized Anti-Xa tests

  5. aPTT Laboratory test

    Time frame: Day of Surgery

    To compare these tests with novel oral anticoagulant specialized Anti-Xa tests

  6. TT Laboratory test

    Time frame: Day of surgery

    To compare these tests with novel oral anticoagulant specialized Anti-Xa tests

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada

Registry information

Official study title

Perioperative Anticoagulant Use (Dabigatran, Rivaroxaban, or Apixaban) for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF).

Acronym: PAUSE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2014
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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