NCT04825158

Brief Summary

Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Status
unknown

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

January 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2024

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

January 21, 2021

Last Update Submit

March 30, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Platelet activation

    Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count

    As soon as possible after onset of anaphylaxis

  • Platelet activation

    Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count

    1-2 hours after the onset of anaphylaxis

  • Platelet activation

    Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count

    24 hours after the onset of anaphylaxis

  • Platelet activation

    Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count

    During the allergic workup (4-6 weeks after)

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will focus on any adult patient with a suspected diagnosis of perioperative anaphylactic shock

You may qualify if:

  • Patient, male or female, adult
  • In the perioperative period
  • In whom the diagnosis of anaphylactic shock is suggested
  • Patient is giving his consent to participate in the study

You may not qualify if:

  • Subject under legal protection
  • Subject under guardianship or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Whole blood * Plasma

MeSH Terms

Conditions

HemoptysisAnaphylaxis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

April 1, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2021

Study Completion

February 9, 2024

Last Updated

April 1, 2021

Record last verified: 2021-03