Perioperative Anticoagulant Use for Surgery Evaluation Emergency Registry

NCT04195113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2023-05-01

No results posted yet for this study

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

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER
  • St. Joseph's Healthcare Hamilton

    collaborator OTHER
  • McMaster University

    lead OTHER

Principal Investigators

  • Deborah Siegal, MD MSc FRCPC · McMaster University

  • James Douketis, MD MSc FRCPC · McMaster University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04195113 on ClinicalTrials.gov