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RecruitingNCT07905911Updated Oct 30, 2026

Maximum Lysis on Thromboelastography as a Marker of Systemic Severity in Acute Allergic Reactions

An observational study in Allergy, Allergic Reactions and Anaphylaxis, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Primary conditionAnaphylaxisRegistry: HypersensitivityReclassifiedWhy we changed it
Registry
Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Anaphylaxis
Why
  1. The study's listed conditions name Anaphylaxis, a narrower term within Hypersensitivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Mayo Clinic · Observational

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
12 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Allergy
  • Allergic Reactions
  • Anaphylaxis
  • Biomarkers / Blood

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Keywords

  • biomarker
  • anaphylaxis
  • allergic reactions
03

In context

Anaphylaxis Reclassified

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's planned enrollment of 250 is above the median of 137 across 48 observational studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Browse Mayo Clinic studies →

Compared within Anaphylaxis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting to the emergency department with suspected allergic reaction, anaphylaxis, or angioedema who can undergo thromboelastography during the acute presentation

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Known inherited coagulation or fibrinolytic disorders.
  • Active major bleeding at presentation.
  • Receipt of thrombolytic therapy.
  • Inability to obtain thromboelastography promptly.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testThromboelastogram

    Blood test - Thromboelastogram

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. Hospital Admission

    Number of participants admitted to the hospital, assessed for association with Maximum Lysis.

    Time frame: 4 years

  2. Intensive Care Utilization

    Number of participants receiving intensive care, assessed for association with Maximum Lysis.

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Sep 2030, 47 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2026
First posted
Oct 30, 2026
StartActual
Oct 23, 2026
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2031
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07905911
Lead sponsor
Mayo Clinic
Responsible party
Ronna L. Campbell (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 30, 2026
Start date
Oct 23, 2026
Primary completion
Sep 2030 (estimated)
Completion
Sep 2031 (estimated)
Last update
Oct 30, 2026

Study contacts

Study Coordinator
Contact
vanmeter.derek@mayo.edu
507-255-5056
Ronna Campbell, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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