Clinical trial

Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

Name

DE MAISTRE 2019

Description

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.

Trial arms

Trial start

2021-12-07

Estimated PCD

2023-04-11

Trial end

2023-04-11

Status

Completed

Treatment

Blood sampling

Arms:

ECMO, Haemorrhagic, Platelet disorder, controls, polytrauma

Size

Primary endpoint

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

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 83, 'type': 'ACTUAL'}}

Updated at

2023-07-25

1 organization

1 product

3 indications

Organization

Centre Hospitalier Universitaire Dijon

Product

Indication

Indication

Indication