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Anticoagulation in Emergency General Surgery

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ClinicalTrials.gov Identifier: NCT04216394
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Brief Summary:
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.

Condition or disease Intervention/treatment
Emergency General Surgery Procedure: Emergency general surgery

Detailed Description:
Emergency general surgery (EGS) represents illnesses of diverse pathology with urgent/emergent treatment needs being the common denominator.(1) 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.1 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.(2,3)

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Anticoagulation in Emergency General Surgery: Who Bleeds More? The ACES Trial
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : August 1, 2021

Intervention Details:
  • Procedure: Emergency general surgery
    multidisciplinary surgery performed for traumatic and non-traumatic acute conditions during the same admission in the hospital.


Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Emergency general surgery patient population taking Direct oral anticoagulants
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216394


Contacts
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Contact: Crystee Cooper, DHEd 214-947-1280 CrysteeCooper@mhd.com
Contact: Jordania L Lilly, MEd 214-947-1280 JordaniaLilly@mhd.com

Locations
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United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: Crystee Cooper, DHEd    214-947-1280    CrysteeCooper@mhd.com   
Contact: Jordania L Lilly, MEd    (214) 947-1280    jordanialilly@mhd.com   
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Michael Truitt, MD Methodist Dallas Medical Center Trauma
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04216394    
Other Study ID Numbers: 049.GME.2019.D
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes