NCT04216394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2020

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

November 27, 2019

Last Update Submit

March 24, 2026

Conditions

Emergency General Surgery

Outcome Measures

Primary Outcomes (3)

  • Rate of operative

    To determine the bleeding risk and need for unplanned intervention

    Oct 2019 - Aug 2021

  • Number of Participants with interventional radiology

    To determine the bleeding risk and need for unplanned intervention

    Oct 2019 - Aug 2021

  • Number of Participants with ultrasound aspiration

    To determine the bleeding risk and need for unplanned intervention

    Oct 2019 - Aug 2021

Interventions

Emergency general surgeryPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency general surgery patient population taking Direct oral anticoagulants

You may qualify if:

  • 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
  • years of age or over

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

  • Michael Truitt, MD

    Methodist Dallas Medical Center Trauma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

January 2, 2020

Study Start

October 31, 2019

Primary Completion

November 13, 2020

Study Completion

November 13, 2020

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)