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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04825158
Other study ID # 8030
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date February 9, 2024

Study information

Verified date March 2021
Source University Hospital, Strasbourg, France
Contact Charles-Ambroise TACQUARD, PHD
Phone +333 69 55 16 08
Email charlesambroise.tacquard@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date February 9, 2024
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Platelet activation Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count 24 hours after the onset of anaphylaxis
Primary 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)
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