Perioperative Anticoagulant Use for Surgery Evaluation Emergency Registry

NCT04195113 | Completed

• 1 other identifier: PAUSE-ER-2019
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 3

Brief Summary

Among patients who are receiving long-term anticoagulant therapy, whether with a direct oral anticoagulant (DOAC) or vitamin K antagonist (VKA), approximately 3-5% who require treatment interruption for a surgery will do so in an urgent/emergency surgery setting. Additionally, there is considerable morbidity and mortality associated with DOAC/VKA management in an urgent/emergency surgery setting. Thus, this prospective registry study aims to identify and compare determinants for perioperative adverse events in DOAC-treated and VKA-treated patients who require an urgent/emergency surgery, and to identify which of these are modifiable. It also aims to describe and compare management of anticoagulant reversal (i.e., non-specific and specific reversal agents) and resource utilization (i.e., blood transfusion) in DOAC- and VKA-treated patients who need an urgent/emergency surgery.

Conditions

Atrial Fibrillation; Venous Thromboembolism; Arterial Vascular Disease

Keywords

anticoagulant; atrial fibrillation; venous thromboembolism; arterial vascular disease; surgery; oral anticoagulant; blood thinner; warfarin; DOAC; interruption; discontinue; emergency; perioperative; vitamin k antagonist

Outcome Measures

Primary Outcomes (4)

• Number of patients who had arterial thromboembolism (ATE)

  Any of the following: stroke, systemic arterial embolism, and/or myocardial infarction. * 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 intraoperatively or by objective imaging (e.g., CT angiography). * Myocardial Infarction: Symptomatic myocardial ischemia, defined by pre-specified clinical and objective EKG- and/or troponin-related criteria.

  Each patient will be followed-up once 30±7-days post-operative

• Number of patients who had venous thromboembolism (VTE)

  Any of the following: symptomatic deep vein thrombosis and/or pulmonary embolism, confirmed by objective imaging studies (e.g., ultrasound, CT pulmonary angiogram, VQ scan).

  Each patient will be followed-up once 30±7-days post-operative

• Number of patients who had major bleeding

  As defined by the International Society on Thrombosis and Haemostasis (ISTH), ≥1 of the criteria below: * 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 ≥20 g/L (1.24 mmol/L) or leading to transfusion ≥2 units whole blood or red cells within 48 hours of the bleed * surgical bleed that leads to intervention (e.g., re-operation) or has one of: (i) interferes with mobilization; (ii) leads to delayed wound healing; or (iii) leads to deep wound infection * surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability associated with: (i) drop in hemoglobin ≥20 g/L (1.24 mmol/L); or (ii) transfusion of ≥2 units whole blood or red cells within 48 hours of the bleed

  Each patient will be followed-up once 30±7-days post-operative

• Number of patients who died

  Death due to any cause

  Each patient will be followed-up once 30±7-days post-operative

Secondary Outcomes (3)

• Number of patients who received adjunctive hemostatic therapies

  Each patient will be followed-up once 30±7-days post-operative

• Number of patients who received specific anticoagulant reversal agents

  Each patient will be followed-up once 30±7-days post-operative

• Number of patients who received blood products

  Each patient will be followed-up once 30±7-days post-operative

Study Arms (2)

Direct Oral Anticoagulants (DOACs)

In this study, DOACs include apixaban, dabigatran, edoxaban and/or rivaroxaban.

Vitamin K Antagonist (VKA)

In this study, the VKA is warfarin.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study cohort will be recruited from urgent care and/or emergency department populations.

You may qualify if:

• Adult (age ≥18 years) receiving a DOAC (dabigatran, rivaroxaban, apixaban or edoxaban) or a VKA (warfarin) for stroke prevention atrial fibrillation/flutter, treatment or secondary prevention of venous thromboembolism or treatment of arterial vascular disease.
• Requires an urgent or emergency surgery and planned surgery is scheduled within 72 hours from the time the decision was made to proceed to surgery (e.g. time of assessment in emergency department, or time of consultation note etc.) or if the time of the decision to proceed to surgery is unavailable, from the time from admission to surgery; or urgent surgery as deemed by Investigator.
• Patient or delegate is willing and able to provide written informed consent while patient is hospitalized and agree to telephone follow-up 30 days (±7 days) after surgery.

You may not qualify if:

• Patient receiving a non-warfarin VKA.
• Patient enrolled in the study previously and had the urgent procedure/surgery (if procedure/surgery cancelled, patient can re-enroll)

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (3)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thromboembolism; Emergencies

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Disease Attributes

Study Officials

• Deborah Siegal, MD MSc FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

• James Douketis, MD MSc FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Deborah Siegal - Principal Investigator

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: August 7, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

CA (3)