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OpenTrials
Completed

NCT Number: NCT04483245

Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

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.

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Key information

Conditions

Collagen Analog Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Platelet Activation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

Blood sampling

Primary outcomes

  1. 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.

Secondary outcomes

  1. Platelet aggregation rate in response to NVH020B

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: CAPTURE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2020
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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