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

Completed
Conditions
Angioedema
Registration Number
NCT06096077
Lead Sponsor
Methodist Health System
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

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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Intubation patients2 weeks

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

Admission proportion2 weeks

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Methodist Dallas Medical Center

🇺🇸

Dallas, Texas, United States

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