Clinical trial NCT06096077: Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department
Official title: Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angioedema
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Intubation patients
timeFrame: 2 weeks
measure: Admission proportion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Charlton Medical Center
name: Feng Lin, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: van den Elzen M, Go MFCL, Knulst AC, Blankestijn MA, van Os-Medendorp H, Otten HG. Efficacy of Treatment of Non-hereditary Angioedema. Clin Rev Allergy Immunol. 2018 Jun;54(3):412-431. doi: 10.1007/s12016-016-8585-0.
citation: Bas M, Greve J, Stelter K, Havel M, Strassen U, Rotter N, Veit J, Schossow B, Hapfelmeier A, Kehl V, Kojda G, Hoffmann TK. A randomized trial of icatibant in ACE-inhibitor-induced angioedema. N Engl J Med. 2015 Jan 29;372(5):418-25. doi: 10.1056/NEJMoa1312524.
citation: Culley CM, DiBridge JN, Wilson GL Jr. Off-Label Use of Agents for Management of Serious or Life-threatening Angiotensin Converting Enzyme Inhibitor-Induced Angioedema. Ann Pharmacother. 2016 Jan;50(1):47-59. doi: 10.1177/1060028015607037. Epub 2015 Sep 28.
citation: Kerrigan MJ, Naik P. C1 Esterase Inhibitor Deficiency. 2023 Jul 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538166/
citation: Busse PJ, Christiansen SC, Riedl MA, Banerji A, Bernstein JA, Castaldo AJ, Craig T, Davis-Lorton M, Frank MM, Li HH, Lumry WR, Zuraw BL. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema. J Allergy Clin Immunol Pract. 2021 Jan;9(1):132-150.e3. doi: 10.1016/j.jaip.2020.08.046. Epub 2020 Sep 6.