Platelet Activation by a Collagen Analogue in Hemorrhagic Situations
Completed
- Conditions
- Collagen AnalogPlatelet ActivationHemorrhage
- Registration Number
- NCT04483245
- Lead Sponsor
- Centre Hospitalier Universitaire Dijon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Inclusion Criteria
-
- person who has given their non-opposition to inclusion
- adult
- Healthy volunteers or controls (patients seen in consultation, without history of hemmorhage, etc.).
or
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B. 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.
- Secondary Outcome Measures
Name Time Method Platelet aggregation rate in response to NVH020B Through study completion, an average of 1 year
Trial Locations
- Locations (1)
Chu Dijon Bourgogne
🇫🇷Dijon, France
Chu Dijon Bourgogne🇫🇷Dijon, France