Platelet Activation by a Collagen Analogue in Hemorrhagic Situations (CAPTURE)

July 24, 2023 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21000
        • CHU dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients coming for a consultation at the Resouce Centre for Haemorrhagic Diseases and Coagulopathies in the Internal Medicine and Haematology Department. Patients admitted to the Emergency Department, and patients admitted to the operating theatre by the Surgical Intensive Care Unit, the Neurovascular Emergency Department, or the Neurosurgery Department.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The expression of P-selectin and activated GPIIb/IIIa (PAC1) at the surface of platelets in flow cytometry in response to NVH020B.
Time Frame: 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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Platelet aggregation rate in response to NVH020B
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Actual)

April 11, 2023

Study Completion (Actual)

April 11, 2023

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DE MAISTRE 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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