Anticoagulation in Emergency General Surgery

Emergency General Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216394
• Other study ID #: 049.GME.2019.D
• Status: Completed
• Start date: October 31, 2019
• Est. completion date: November 13, 2020

Study information

• Verified date: February 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 13, 2020
• Est. primary completion date: November 13, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency General Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of operative	To determine the bleeding risk and need for unplanned intervention	Oct 2019 - Aug 2021
Primary	Number of Participants with interventional radiology	To determine the bleeding risk and need for unplanned intervention	Oct 2019 - Aug 2021
Primary	Number of Participants with ultrasound aspiration	To determine the bleeding risk and need for unplanned intervention	Oct 2019 - Aug 2021