Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

Centre Hospitalier Universitaire Dijon1 site in 1 country83 target enrollmentDecember 7, 2021

ConditionsCollagen Analog Platelet Activation Hemorrhage

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Collagen Analog
Sponsor: Centre Hospitalier Universitaire Dijon
Enrollment: 83
Locations: 1
Primary Endpoint: The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Dijon University Hospital and the Dijon-based NVH Medicinal Company have developed a recombinant mini-collagen NVH020B with platelet and Willebrand factor binding activity. Its small size and granular, non-fibrillar presentation make it suitable for use as an injectable hemostat in patients with a hemorrhage or other emergency under antiplatelet therapy.

Registry

clinicaltrials.gov

Start Date

December 7, 2021

End Date

April 11, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire Dijon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•- person who has given their non-opposition to inclusion
•Healthy volunteers or controls (patients seen in consultation, without history of hemmorhage, etc.).
•patients with acute bleeding: polytraumatized, or hemorrhage or intracerebral haemorrhage, or bleeding complications at the end surgery (in particular cardiac surgery with ECMO) or
•patients with antiplatelet therapy or
•patients with thrombocytopenia/thrombopathy

Exclusion Criteria

•protected adults (curatorship, guardianship)
•person deprived of their liberty by judicial or administrative decision
•pregnant, parturient or breastfeeding woman
•person unable to express their non-opposition
•platelet transfusion on initial management

Outcomes

Primary Outcomes

The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B.

Time Frame: Through study completion, an average of 1 year

These 2 markers are absent on the surface of resting platelets. The expression of these 2 markers will make it possible to evaluate the role of the mini-collagen as an activator.