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HEMOCANOPE: Study of the Role of Hemostasis in Perioperative Anaphylaxis

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04825158
Collaborator
(none)
30
Enrollment
34.3
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of the Role of Hemostasis in Perioperative Anaphylaxis
    Anticipated Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2021
    Anticipated Study Completion Date :
    Feb 9, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Platelet activation [As soon as possible after onset of anaphylaxis]

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

    2. Platelet activation [1-2 hours after the onset of anaphylaxis]

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

    3. Platelet activation [24 hours after the onset of anaphylaxis]

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

    4. Platelet activation [During the allergic workup (4-6 weeks after)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • Subject under legal protection

    • Subject under guardianship or guardianship

    • Anemia less than 7 g /dl at the time of inclusion

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT04825158
    Other Study ID Numbers:
    • 8030
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemoptysis
    Anaphylaxis
    Shock

    Study Results

    No Results Posted as of Apr 1, 2021