AngioedemaNCT06096077
Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department
An observational study of Angioedema, run by Methodist Health System at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angioedema
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to 23 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- •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.
Who cannot join
- •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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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
Read the 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).
- Conditions
- Angioedema
- Medical subject headings
- Angioedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | ED at MCMC for ACEi-AE with TXA | |
| Retrospective Chort | ED at MCMC for ACEi-AE without TXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation patients
Proportion of patients who required intubation during their hospital length of stay.
Measured: 2 weeks
Admission proportion
The proportion of admissions to the ICU or another floor within MCMC Time to hospital discharge.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 Nov 2022
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Lin, PharmD, Principal investigator, Methodist Charlton Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096077
- Sponsor's protocol ID
- 114.PHA.2022.C
- Status last verified
- Jan 2024
- First submitted
- 17 Oct 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Moellman JJ, Bernstein JA, Lindsell C, Banerji A, Busse PJ, Camargo CA Jr, Collins SP, Craig TJ, Lumry WR, Nowak R, Pines JM, Raja AS, Riedl M, Ward MJ, Zuraw BL, Diercks D, Hiestand B, Campbell RL, Schneider S, Sinert R; American College of Allergy, Asthma & Immunology (ACAAI); Society for Academic Emergency Medicine (SAEM). A consensus parameter for the evaluation and management of angioedema in the emergency department. Acad Emerg Med. 2014 Apr;21(4):469-84. doi: 10.1111/acem.12341.
PubMed 24730413Zuraw BL, Bernstein JA, Lang DM, Craig T, Dreyfus D, Hsieh F, Khan D, Sheikh J, Weldon D, Bernstein DI, Blessing-Moore J, Cox L, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph CR, Schuller DE, Spector SL, Tilles SA, Wallace D; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology. A focused parameter update: hereditary angioedema, acquired C1 inhibitor deficiency, and angiotensin-converting enzyme inhibitor-associated angioedema. J Allergy Clin Immunol. 2013 Jun;131(6):1491-3. doi: 10.1016/j.jaci.2013.03.034.
PubMed 23726531Banerji A, Clark S, Blanda M, LoVecchio F, Snyder B, Camargo CA Jr. Multicenter study of patients with angiotensin-converting enzyme inhibitor-induced angioedema who present to the emergency department. Ann Allergy Asthma Immunol. 2008 Apr;100(4):327-32. doi: 10.1016/S1081-1206(10)60594-7.
PubMed 18450117Gabb GM, Ryan P, Wing LM, Hutchinson KA. Epidemiological study of angioedema and ACE inhibitors. Aust N Z J Med. 1996 Dec;26(6):777-82. doi: 10.1111/j.1445-5994.1996.tb00624.x.
PubMed 9028507Sarkar P, Nicholson G, Hall G. Brief review: angiotensin converting enzyme inhibitors and angioedema: anesthetic implications. Can J Anaesth. 2006 Oct;53(10):994-1003. doi: 10.1007/BF03022528.
PubMed 16987854Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med. 2008 Sep 4;359(10):1027-36. doi: 10.1056/NEJMcp0803977. No abstract available.
PubMed 18768946van 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.
PubMed 27672078Bas 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.
PubMed 25629740Culley 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.
PubMed 26416949Kerrigan MJ, Naik P. C1 Esterase Inhibitor Deficiency. [Updated 2022 Jul 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538166/
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.
PubMed 32898710
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department
- ClinicalTrials.gov ID
- NCT06096077
- Acronym / sponsor ID
- 114.PHA.2022.C
- Conditions
- Angioedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –ED at MCMC for ACEi-AE with TXA |
| Retrospective Chort | – | –ED at MCMC for ACEi-AE without TXA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- •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.
Key exclusion criteria (1 listed)
- •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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intubation patients
Time frame: 2 weeks
Proportion of patients who required intubation during their hospital length of stay.
Admission proportion
Time frame: 2 weeks
The proportion of admissions to the ICU or another floor within MCMC Time to hospital discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Background: PubMed 24730413Moellman JJ, Bernstein JA, Lindsell C, Banerji A, Busse PJ, Camargo CA Jr, Collins SP, Craig TJ, Lumry WR, Nowak R, Pines JM, Raja AS, Riedl M, Ward MJ, Zuraw BL, Diercks D, Hiestand B, Campbell RL, Schneider S, Sinert R; American College of Allergy, Asthma & Immunology (ACAAI); Society for Academic Emergency Medicine (SAEM). A consensus parameter for the evaluation and management of angioedema in the emergency department. Acad Emerg Med. 2014 Apr;21(4):469-84. doi: 10.1111/acem.12341.
- Background: PubMed 23726531Zuraw BL, Bernstein JA, Lang DM, Craig T, Dreyfus D, Hsieh F, Khan D, Sheikh J, Weldon D, Bernstein DI, Blessing-Moore J, Cox L, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph CR, Schuller DE, Spector SL, Tilles SA, Wallace D; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology. A focused parameter update: hereditary angioedema, acquired C1 inhibitor deficiency, and angiotensin-converting enzyme inhibitor-associated angioedema. J Allergy Clin Immunol. 2013 Jun;131(6):1491-3. doi: 10.1016/j.jaci.2013.03.034.
- Background: PubMed 18450117Banerji A, Clark S, Blanda M, LoVecchio F, Snyder B, Camargo CA Jr. Multicenter study of patients with angiotensin-converting enzyme inhibitor-induced angioedema who present to the emergency department. Ann Allergy Asthma Immunol. 2008 Apr;100(4):327-32. doi: 10.1016/S1081-1206(10)60594-7.
- Background: PubMed 9028507Gabb GM, Ryan P, Wing LM, Hutchinson KA. Epidemiological study of angioedema and ACE inhibitors. Aust N Z J Med. 1996 Dec;26(6):777-82. doi: 10.1111/j.1445-5994.1996.tb00624.x.
- Background: PubMed 16987854Sarkar P, Nicholson G, Hall G. Brief review: angiotensin converting enzyme inhibitors and angioedema: anesthetic implications. Can J Anaesth. 2006 Oct;53(10):994-1003. doi: 10.1007/BF03022528.
- Background: PubMed 18768946Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med. 2008 Sep 4;359(10):1027-36. doi: 10.1056/NEJMcp0803977. No abstract available.
- Background: PubMed 27672078van 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.
- Background: PubMed 25629740Bas 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.
- Background: PubMed 26416949Culley 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.
- BackgroundKerrigan MJ, Naik P. C1 Esterase Inhibitor Deficiency. [Updated 2022 Jul 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538166/
- Background: PubMed 32898710Busse 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Lin, PharmD principal investigator
Methodist Charlton Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioedema, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation patients (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06096077, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.