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Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

Completed
Conditions
Collagen Analog
Platelet Activation
Hemorrhage
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
NameTimeMethod
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
NameTimeMethod
Platelet aggregation rate in response to NVH020BThrough study completion, an average of 1 year

Trial Locations

Locations (1)

Chu Dijon Bourgogne

🇫🇷

Dijon, France

Chu Dijon Bourgogne
🇫🇷Dijon, France

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