Collagen AnalogCAPTURENCT04483245
Platelet Activation by a Collagen Analogue in Hemorrhagic Situations
An observational study of Collagen Analog and Platelet Activation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Collagen Analog, Platelet Activation, Hemorrhage
- What is being tested?
- Blood sampling
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2021to 11 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- - 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Collagen Analog, Platelet Activation, Hemorrhage
- Being tested
- Blood sampling
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| controls | persons free of hemorrhage or haemostasis disorder Receives: Biological: Blood sampling | |
| Haemorrhagic | Acute hemorrhagic patient Receives: Biological: Blood sampling | |
| ECMO | ECMO surgery patient with hemorrhagic complication Receives: Biological: Blood sampling | |
| polytrauma | Not described Receives: Biological: Blood sampling | |
| Platelet disorder | Patient with an identified platelet disorder or treated with antiplatelet agents Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Platelet aggregation rate in response to NVH020B
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start7 Dec 2021
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen AnalogStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483245
- Sponsor's protocol ID
- DE MAISTRE 2019
- Acronym
- CAPTURE
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activation by a Collagen Analogue in Hemorrhagic Situations
- ClinicalTrials.gov ID
- NCT04483245
- Acronym / sponsor ID
- CAPTURE / DE MAISTRE 2019
- Conditions
- Collagen Analog, Platelet Activation, Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| controls | – | Biological: Blood samplingpersons free of hemorrhage or haemostasis disorder |
| Haemorrhagic | – | Biological: Blood samplingAcute hemorrhagic patient |
| ECMO | – | Biological: Blood samplingECMO surgery patient with hemorrhagic complication |
| polytrauma | – | Biological: Blood sampling |
| Platelet disorder | – | Biological: Blood samplingPatient with an identified platelet disorder or treated with antiplatelet agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- - 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling | Biological | ECMO, Haemorrhagic, Platelet disorder, controls, polytrauma |
Primary outcome
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.
1 secondary outcome
Platelet aggregation rate in response to NVH020B
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Collagen Analog and Platelet Activation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.