CompletedNot Applicable

Perioperative Anticoagulant Use for Surgery Evaluation Emergency Registry

Canada242 participantsStarted 2019-08-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

What they're measuring

Number of patients who had arterial thromboembolism (ATE)

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

Number of patients who had venous thromboembolism (VTE)

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

Number of patients who had major bleeding

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

Number of patients who died

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

Trial details

NCT IDNCT04195113

SponsorMcMaster University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Atrial Fibrillation trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of patients who had arterial thromboembolism (ATE)

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

Number of patients who had venous thromboembolism (VTE)

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

Number of patients who had major bleeding

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

Number of patients who died

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