NCT05690542

Brief Summary

The main objective is to study the effect of engineered nanoparticles SPIONs (superparamagnetic iron oxide) on hemostasis. Nanoparticles will be incubated in blood and platelet aggregation will be measured. In parallel, nanoparticles will also be incubated in blood and then plasma proteins adsorbed on them will be separated and analyzed. The proteins found on the nanoparticles will be linked to the platelet aggregation observed to help developing innovative protein functionalized nanoprobes for optimized nanomedicine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 10, 2023

Last Update Submit

January 10, 2023

Conditions

Coagulation Tests

Outcome Measures

Primary Outcomes (1)

  • impact of nanoparticles on coagulation tests ou platelet functions

    at the baseline

Secondary Outcomes (1)

  • Difference of behaviour of the nanoparticles (N=10 preparations) on coagulation cascade and platelet functions

    at the baseline

Study Arms (2)

patients from intensive care units

patients with hemostasis disorders (coagulation and/or platelets), antiplatelet and/or anticoagulant treatment

Other: blood tests

controls

healthy people

Other: blood tests

Interventions

blood testsOTHER

evaluate the possible impact of iron oxide nanoparticles (superparamagnetic iron oxide = SPIONs) (N=10) in the blood circulation;

controlspatients from intensive care units

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Leftover plasma sample from controls and patients hospitalized in CHU Dijon

You may qualify if:

  • all people

You may not qualify if:

  • patient under 18 years old, legal protection measure, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU DIJON BOURGOGNE - laboratoire mixte

Dijon, 21000, France

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

DE MAISTRE Emmanuel

CONTACT

380293257emmanuel.demaistre@chu-dijon.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

FR(1)