Anticoagulation in Emergency General Surgery

NCT ID: NCT04216394

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-11-13

Brief Summary

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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

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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.

Conditions

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Emergency General Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Emergency general surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Truitt, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Dallas Medical Center Trauma

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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049.GME.2019.D

Identifier Type: -

Identifier Source: org_study_id

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