Nanoparticles in Blood: Understanding and Controlling Protein Corona for Optimized Nanomedicine (NANOBLORONA)

January 10, 2023 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

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

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 to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Leftover plasma sample from controls and patients hospitalized in CHU Dijon

Description

Inclusion Criteria:

  • all people

Exclusion Criteria:

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

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients from intensive care units
patients with hemostasis disorders (coagulation and/or platelets), antiplatelet and/or anticoagulant treatment
Other: blood tests
evaluate the possible impact of iron oxide nanoparticles (superparamagnetic iron oxide = SPIONs) (N=10) in the blood circulation;
controls
healthy people
Other: blood tests
evaluate the possible impact of iron oxide nanoparticles (superparamagnetic iron oxide = SPIONs) (N=10) in the blood circulation;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
impact of nanoparticles on coagulation tests ou platelet functions
Time Frame: at the baseline
at the baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference of behaviour of the nanoparticles (N=10 preparations) on coagulation cascade and platelet functions
Time Frame: at the baseline
at the baseline

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 (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Estimate)

January 19, 2023

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DEMAISTRE CNRS 2022

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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Locations

3
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