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OpenTrials
Completed

NCT Number: NCT04216394

Anticoagulation in Emergency General Surgery

While DOACs are increasing in use in the EGS patient population, the risk of bleeding and the reversal of these agents to reduce hemorrhage is still evolving. Given the paucity of data regarding the impact of DOACs in this patient population, it becomes empiric to identify bleeding patterns and outcomes in the EGS population taking DOACs. We hypothesize that patients taking a DOAC will have a higher bleeding incidence and need for an unplanned intervention secondary to hemorrhage in EGS patients undergoing an urgent or emergent operation when compared to patients taking warfarin and antiplatelets.

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Key information

Conditions

Emergency General Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

Emergency general surgery (EGS) represents illnesses of diverse pathology with urgent/emergent treatment needs being the common denominator.A characteristic feature of EGS is its limitation in patient preparation. It is difficult and often impossible to eliminate certain patient dependent factors to reduce the operative risk. It has been reported that the annual case rate in the EGS population is (1,290 per 100,000) higher than the sum of all cancer diagnoses. The EGS burden is substantial and continues to increase. The elderly patient population represents 48% of the overall EGS population. With the increase in the prevalence of atherosclerotic disease in the elderly there has been an increase in the use of antiplatelets and anticoagulants.

Who can participate

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

Inclusion criteria

  • All patients who are confirmed to be taking dabigatran, rivaroxaban, apixaban, warfarin and antiplatelet therapy (aspirin, clopidogril, ticagrelor) undergoing an urgent or emergent surgical intervention by the emergency general surgery service within 24 hours of arrival to the hospital
  • 18 years of age or over

Exclusion criteria

  • Prisoners
  • Pregnant patients
  • Those who received an index operation at an outside facility and were transferred
  • Under 18 years of age

Treatment and study plan

Emergency General Surgery

Procedure

multidisciplinary surgery performed for traumatic and non-traumatic acute conditions during the same admission in the hospital.

Primary outcomes

  1. Rate of operative

    Time frame: Oct 2019 - Aug 2021

    To determine the bleeding risk and need for unplanned intervention

  2. Number of Participants with interventional radiology

    Time frame: Oct 2019 - Aug 2021

    To determine the bleeding risk and need for unplanned intervention

  3. Number of Participants with ultrasound aspiration

    Time frame: Oct 2019 - Aug 2021

    To determine the bleeding risk and need for unplanned intervention

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Anticoagulation in Emergency General Surgery: Who Bleeds More? The ACES Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 2, 2020
Registry last updated
Mar 27, 2026

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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