Study of the Role of Hemostasis in Perioperative Anaphylaxis

Perioperative Complication Clinical Trial

— HEMOCANOPE  

Official title:

Study of the Role of Hemostasis in Perioperative Anaphylaxis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04825158
• Other study ID #: 8030
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Anaphylaxis
• Hemoptysis
• Perioperative Complication
• Shock

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)