AllergyNCT07905911
Maximum Lysis on Thromboelastography as a Marker of Systemic Severity in Acute Allergic Reactions
An observational study of Allergy and Allergic Reactions, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to better understand the mechanisms behind allergic reactions. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergy, Allergic Reactions, Anaphylaxis
- What is being tested?
- Thromboelastogram
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2026to Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to the emergency department with suspected allergic reaction, anaphylaxis, or angioedema who can undergo thromboelastography during the acute presentation
Who may be able to join
- Age 12 years or older.
- Presentation to the emergency department with suspected allergic reaction, anaphylaxis, or angioedema based on chief concern.
- Ability to obtain thromboelastography during the acute presentation.
Who cannot join
- Known inherited coagulation or fibrinolytic disorders.
- Active major bleeding at presentation.
- Receipt of thrombolytic therapy.
- Inability to obtain thromboelastography promptly.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Research Coordinator, 507-255-5056
About this study
The purpose of this research is to better understand the mechanisms behind allergic reactions.
Read the detailed description
The goal of this study is to integrate real-time physiologic markers (maximum lysis) with future molecular insights, advancing the field toward biologically informed anaphylaxis endotypes and precision risk stratification.
- Conditions
- Allergy, Allergic Reactions, Anaphylaxis, Biomarkers / Blood
- Being tested
- Thromboelastogram
- Keywords
- biomarker, anaphylaxis, allergic reactions
- Medical subject headings
- Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastogramDiagnostic test
Blood test - Thromboelastogram
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Lysis by Allergic Reaction Severity
Maximum Lysis measured by EXTEM thromboelastography and compared across World Allergy Organization (WAO) grades 1-5 and between mild (grades 1-2) and systemic (grades 3-5) reactions. Higher grades indicate greater severity.
Measured: Baseline
Secondary outcomes (2)
Hospital Admission
Number of participants admitted to the hospital, assessed for association with Maximum Lysis.
Measured: 4 years
Intensive Care Utilization
Number of participants receiving intensive care, assessed for association with Maximum Lysis.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start23 Oct 2026
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronna L. Campbell, Mayo Clinic
- Investigators
- Ronna Campbell, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905911
- Sponsor's protocol ID
- 26-006271
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kienbacher CL, Schoergenhofer C, Ruzicka G, Grafeneder J, Hufnagl C, Jilma B, Schwameis M, Herkner H. Thromboelastography in acute immunologic reactions: a prospective pilot study. Res Pract Thromb Haemost. 2024 Apr 27;8(4):102425. doi: 10.1016/j.rpth.2024.102425. eCollection 2024 May.
PubMed 38974798
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximum Lysis on Thromboelastography as a Marker of Systemic Severity in Acute Allergic Reactions
- ClinicalTrials.gov ID
- NCT07905911
- Acronym / sponsor ID
- 26-006271
- Conditions
- Allergy, Allergic Reactions, Anaphylaxis, Biomarkers / Blood
- Keywords
- biomarker, anaphylaxis, allergic reactions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 30 Oct 2026 (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.
The purpose of this research is to better understand the mechanisms behind allergic reactions.
Detailed description
The goal of this study is to integrate real-time physiologic markers (maximum lysis) with future molecular insights, advancing the field toward biologically informed anaphylaxis endotypes and precision risk stratification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to the emergency department with suspected allergic reaction, anaphylaxis, or angioedema who can undergo thromboelastography during the acute presentation
Key inclusion criteria (3 listed)
- Age 12 years or older.
- Presentation to the emergency department with suspected allergic reaction, anaphylaxis, or angioedema based on chief concern.
- Ability to obtain thromboelastography during the acute presentation.
Key exclusion criteria (4 listed)
- Known inherited coagulation or fibrinolytic disorders.
- Active major bleeding at presentation.
- Receipt of thrombolytic therapy.
- Inability to obtain thromboelastography promptly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboelastogramBlood test - Thromboelastogram | Diagnostic test | – |
Primary outcome
Maximum Lysis by Allergic Reaction Severity
Time frame: Baseline
Maximum Lysis measured by EXTEM thromboelastography and compared across World Allergy Organization (WAO) grades 1-5 and between mild (grades 1-2) and systemic (grades 3-5) reactions. Higher grades indicate greater severity.
2 secondary outcomes
Hospital Admission
Time frame: 4 years
Intensive Care Utilization
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 38974798Kienbacher CL, Schoergenhofer C, Ruzicka G, Grafeneder J, Hufnagl C, Jilma B, Schwameis M, Herkner H. Thromboelastography in acute immunologic reactions: a prospective pilot study. Res Pract Thromb Haemost. 2024 Apr 27;8(4):102425. doi: 10.1016/j.rpth.2024.102425. eCollection 2024 May.
- Individual participant dataSharing planned: No
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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.
Ronna Campbell, MD principal investigator
Mayo Clinic
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 Allergy and Allergic Reactions, run by Mayo Clinic 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (507-255-5056, vanmeter.derek@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Lysis by Allergic Reaction Severity (time frame: Baseline). 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 NCT07905911, which also lists 1 linked publication.
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 30 Oct 2026.