NCT04046731

Brief Summary

The researchers are trying to develop an allergy skin test to help predict allergic responses to medications commonly given to patients during surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

August 5, 2019

Last Update Submit

February 1, 2022

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Non-Irritant Concentrations to common NMBAs

    Determine the NIC to common NMBAs

    1 Year

Secondary Outcomes (2)

  • Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs

    1 Year

  • Max Concentration used when skin testing to NMBAs

    1 Year

Study Arms (1)

Study Group

EXPERIMENTAL

Study team is developing a new diagnostic skin testing procedure for patients who receive NMBAs during surgery in order to determine Negative Predictive Values and Non-Irritant Concentrations.

Diagnostic Test: Skin Testing

Interventions

Skin TestingDIAGNOSTIC_TEST

Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults \> or = to 18 y/o undergoing surgery

You may not qualify if:

  • Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.

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

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Alexei Gonzalez Estrada, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 6, 2019

Study Start

September 20, 2019

Primary Completion

December 30, 2021

Study Completion

December 31, 2021

Last Updated

February 2, 2022

Record last verified: 2022-02

Locations

US(1)