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NCT04483245 Clinical Trial

Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

Hemorrhage Clinical Trial

— CAPTURE  

Official title:
Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04483245
Other study ID # DE MAISTRE 2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 7, 2021
Est. completion date April 11, 2023

Study information
Verified date July 2023
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date April 11, 2023
Est. primary completion date April 11, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Blood sampling
Blood sampling

Locations
Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B. 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. Through study completion, an average of 1 year
Secondary Platelet aggregation rate in response to NVH020B Through study completion, an average of 1 year
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