Platelet Activation by a Collagen Analogue in Hemorrhagic Situations
CAPTURE
1 other identifier
observational
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedStudy Start
First participant enrolled
December 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2023
CompletedJuly 25, 2023
July 1, 2023
1.3 years
July 17, 2020
July 24, 2023
Conditions
Outcome Measures
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.
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 Outcomes (1)
Platelet aggregation rate in response to NVH020B
Through study completion, an average of 1 year
Study Arms (5)
controls
persons free of hemorrhage or haemostasis disorder
Haemorrhagic
Acute hemorrhagic patient
ECMO
ECMO surgery patient with hemorrhagic complication
polytrauma
Platelet disorder
Patient with an identified platelet disorder or treated with antiplatelet agents
Interventions
Eligibility Criteria
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.
You may qualify if:
- adult
- Healthy volunteers or controls (patients seen in consultation, without history of hemmorhage, etc.).
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Dijon Bourgogne
Dijon, 21000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 23, 2020
Study Start
December 7, 2021
Primary Completion
April 11, 2023
Study Completion
April 11, 2023
Last Updated
July 25, 2023
Record last verified: 2023-07