NCT04125420

Brief Summary

Researchers are trying to study the natural history of allergic reactions during anesthesia and its causes and risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3.5 years

First QC Date

July 28, 2019

Last Update Submit

February 1, 2022

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Incidence.

    Current estimates are between 1:400 to 1:10,000 surgeries mostly based on retrospective reviews. We will report incidence based on numbers of event/number of surgeries

    2-3 years

Secondary Outcomes (1)

  • Risk factors

    2-3 years

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults undergoing surgery at Mayo Clinic Florida

You may qualify if:

  • Patients over age 18 undergoing surgery at Mayo Clinic Florida

You may not qualify if:

  • Minors under age 18
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Alexei Gonzalez Estrada, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2019

First Posted

October 14, 2019

Study Start

August 3, 2018

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

February 2, 2022

Record last verified: 2022-02

Locations

US(1)