An observational study in Angioedema, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Methodist Health System · Observational
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
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).
69 studies on the registry are indexed under Angioedema; 16 are open to participants now.
This study's enrollment of 50 is below the median of 181 across 19 observational studies indexed under Angioedema.
Browse Angioedema studies →Methodist Health System is the lead sponsor of 170 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
•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.
ED at MCMC for ACEi-AE with TXA
ED at MCMC for ACEi-AE without TXA
Intubation patients
Proportion of patients who required intubation during their hospital length of stay.
Time frame: 2 weeks
Admission proportion
The proportion of admissions to the ICU or another floor within MCMC Time to hospital discharge.
Time frame: 2 weeks
Plan to share: Yes — Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 2 years
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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