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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05690542

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coagulation Tests	Other: blood tests

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	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;

Arm

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;

Outcome Measures

Primary Outcome Measures

impact of nanoparticles on coagulation tests ou platelet functions [at the baseline]

Secondary Outcome Measures

Difference of behaviour of the nanoparticles (N=10 preparations) on coagulation cascade and platelet functions [at the baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

all people

Exclusion Criteria:

patient under 18 years old, legal protection measure, pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU DIJON BOURGOGNE - laboratoire mixte	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT05690542

Other Study ID Numbers:

DEMAISTRE CNRS 2022

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 19, 2023