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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
| St. Joseph's Healthcare Hamilton | OTHER |
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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.
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. Assuming that approximately 500,000 to 800,000 patients per year in the U.S. and E.U. will require perioperative management for a surgery/procedure, the investigators estimate that approximately 20,000 to 25,000 patients will require an urgent/emergency surgery. Although this represents a small proportion of patients who require anticoagulant interruption, there is considerable morbidity and mortality associated with DOAC/VKA management in an urgent/emergency surgery setting. Thus, for VKA-treated patients, rates of thromboembolism, major bleeding and mortality are 10.5%, 22.9%, and 2.9%, respectively. Similarly, for DOAC-treated patients who require an urgent/emergency surgery, rates of thromboembolism, major bleeding and mortality are 7.4%, 17.6%, and 1.5%, respectively. By comparison, rates of these outcomes for DOAC/VKA-treated patients who need elective surgery are ~0.5-1.0%, ~1-3%, and <0.5%, respectively. Most studies have focused on the perioperative anticoagulant management of patients who require an elective surgery/procedure. To the investigators' knowledge, few studies have focused on the assessment of adverse outcomes in an urgent/emergency perioperative setting among anticoagulated patients. Thus, this prospective registry study aims to 1) 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, and 2) 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. The data gained from this study will generate hypotheses for subsequent prospective studies that would potentially assess different management strategies in this clinical setting (e.g., use of DOAC antidote- vs. prothrombin complex concentrate-based management).
Given the exploratory, hypothesis-generating nature of the proposed study, the sample size is one of convenience, comprising 200 DOAC- and 200 warfarin-treated patients. Patients will be recruited from 30 clinical sites in Canada, the US, and Europe. With 30 clinical sites, the investigators estimate that 3-5 patients/month (60-72/yr) per arm can be recruited, corresponding to an overall rate of 180-216 over 3 years. Each study patient will participate for approximately 4 weeks, with one follow-up phone call at 4 weeks post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who had arterial thromboembolism (ATE) | Any of the following: stroke, systemic arterial embolism, and/or myocardial infarction.
| 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:
| Each patient will be followed-up once 30±7-days post-operative |
| Number of patients who died |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who received adjunctive hemostatic therapies | For example, prothrombin complex concentrates, FEIBA, tranexamic acid, etc. | Each patient will be followed-up once 30±7-days post-operative |
| Number of patients who received specific anticoagulant reversal agents |
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Inclusion Criteria:
Exclusion Criteria:
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Study cohort will be recruited from urgent care and/or emergency department populations.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Siegal, MD MSc FRCPC | McMaster University | Principal Investigator |
| James Douketis, MD MSc FRCPC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | Canada | |||
| Juravinski Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D054556 | Venous Thromboembolism |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Death due to any cause |
| Each patient will be followed-up once 30±7-days post-operative |
For example, idarucizumab (for dabigatran), andexanet alfa (for factor Xa inhibitors), vitamin K (for VKA), prothrombin complex concentrates (for VKA) etc. |
| Each patient will be followed-up once 30±7-days post-operative |
| Number of patients who received blood products | For example, packed red blood cells, platelets, plasma, cryoprecipitate, fibrinogen, etc. | Each patient will be followed-up once 30±7-days post-operative |
| Hamilton |
| Ontario |
| Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D020969 | Disease Attributes |