Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

Completed

• Conditions: Collagen Analog; Platelet Activation; Hemorrhage
• Interventions: Biological: Blood sampling

• 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

Study Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Study Start: 2021-12-07
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

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

Arm && Interventions

Group	Intervention	Description
controls	Blood sampling	persons free of hemorrhage or haemostasis disorder
polytrauma	Blood sampling	-
Haemorrhagic	Blood sampling	Acute hemorrhagic patient
ECMO	Blood sampling	ECMO surgery patient with hemorrhagic complication
Platelet disorder	Blood sampling	Patient with an identified platelet disorder or treated with antiplatelet agents

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