Anticoagulation in Emergency General Surgery

Completed

• Conditions: Emergency General Surgery

• Registration Number: NCT04216394
• Lead Sponsor: 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.

Detailed 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.

Study Timeline

• Study Start: 2019-10-31
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Primary Completion: 2020-11-13
• Study Completion: 2020-11-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of operative	Oct 2019 - Aug 2021	To determine the bleeding risk and need for unplanned intervention
Number of Participants with interventional radiology	Oct 2019 - Aug 2021	To determine the bleeding risk and need for unplanned intervention
Number of Participants with ultrasound aspiration	Oct 2019 - Aug 2021	To determine the bleeding risk and need for unplanned intervention

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States