Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

NCT ID: NCT04483245

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-07

Study Completion Date

2023-04-11

Brief Summary

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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

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Conditions

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Collagen Analog Platelet Activation Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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controls

persons free of hemorrhage or haemostasis disorder

Blood sampling

Intervention Type BIOLOGICAL

Blood sampling

Haemorrhagic

Acute hemorrhagic patient

Blood sampling

Intervention Type BIOLOGICAL

Blood sampling

ECMO

ECMO surgery patient with hemorrhagic complication

Blood sampling

Intervention Type BIOLOGICAL

Blood sampling

polytrauma

Blood sampling

Intervention Type BIOLOGICAL

Blood sampling

Platelet disorder

Patient with an identified platelet disorder or treated with antiplatelet agents

Blood sampling

Intervention Type BIOLOGICAL

Blood sampling

Interventions

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Blood sampling

Blood sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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DE MAISTRE 2019

Identifier Type: -

Identifier Source: org_study_id

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