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Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department

Sponsor
Methodist Health System (Other)
Overall Status
Completed
CT.gov ID
NCT06096077
Collaborator
(none)
50
Enrollment
1
Location
8.7
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Angiotensin-converting enzyme inhibitor ACEi induced angioedema ACEi-AE is defined as physical swelling of the deep skin layers or mucous membranes due to increased vascular permeability and leakage of fluid into the interstitial space caused while taking an ACEi

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Angiotensin-converting enzyme inhibitor ACEi induced angioedema ACEi-AE most commonly affects the lips, mouth, face, upper airway, and less commonly the gastrointestinal tract. This condition may lead to life-threatening airway compromise which would require emergent intubation. Currently, strong evidence is lacking to help guide management of ACEi-AE in the emergency department (ED).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department
    Actual Study Start Date :
    Nov 30, 2022
    Actual Primary Completion Date :
    Aug 23, 2023
    Actual Study Completion Date :
    Aug 23, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Retrospective Cohort

    ED at MCMC for ACEi-AE with TXA
    Retrospective Chort

    ED at MCMC for ACEi-AE without TXA

    Outcome Measures

    Primary Outcome Measures

    1. Intubation patients [2 weeks]

      Proportion of patients who required intubation during their hospital length of stay.

    2. Admission proportion [2 weeks]

      The proportion of admissions to the ICU or another floor within MCMC Time to hospital discharge.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must be ≥ 18 years old, be diagnosed with suspected ACEi-AE (with ACEi use). ACEi use is defined as patient-reported use or evidence indicating use listed in the chart.
    Exclusion Criteria:
    • Patients will be excluded if they have an allergy to TXA or any components of the formulation, present with an urticaria, have a personal or family history of hereditary angioedema, or received TXA administration in another department besides the ED.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Dallas Medical Center Dallas Texas United States 75203

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

    • Principal Investigator: Feng Lin, PharmD, Methodist Charlton Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT06096077
    Other Study ID Numbers:
    • 114.PHA.2022.C
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Angioedema
    Emergencies

    Study Results

    No Results Posted as of Oct 23, 2023