NCT01305161

Brief Summary

To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which may be used for an ulterior anaesthesia in case of allergy to one given NMB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

February 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 13, 2026

Status Verified

January 1, 2019

Enrollment Period

7.8 years

First QC Date

February 24, 2011

Last Update Submit

March 11, 2026

Conditions

Allergy

Keywords

1Allergy2 Neuromuscular blockers

Outcome Measures

Primary Outcomes (1)

  • Allergy diagnosis assessed by cytometry flow data

    At Day 1

Interventions

Blood simpleOTHER

Single Blood simple at Day 1

Eligibility Criteria

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

You may qualify if:

  • patients aged at least 18 years,
  • patients having experienced an IgE dependant per-anaesthetic reaction
  • affiliated to a social security

You may not qualify if:

  • patients having taken anti-histamine drugs and corticoids during the last 8 days
  • patients submitted to a juridical protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Service d'Allergologie

Angers, France

Location

Service d'Immuno-allergologie

Bordeaux, France

Location

Laboratoire Immunologie et Immunogénétique

Limoges, France

Location

Service d'Anesthésie Réanimation

Nancy, France

Location

Related Publications (1)

  • Place of the basophil activation test in the diagnosis of neuromuscular blocking agent's allergy. Immunological multicenter study. See : https://www.sciencedirect.com/science/article/pii/S1877032024003920 https://doi.org/10.1016/j.reval.2024.104171

    RESULT

Related Links

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 28, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2019

Study Completion

January 1, 2021

Last Updated

March 13, 2026

Record last verified: 2019-01

Locations

FR(4)