Nanoparticles in Blood: Understanding and Controlling Pro... | NCT05690542

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

NCT05690542

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Unknown status

Last Update Posted

Jan 19, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Coagulation Tests

Interventions

blood tests

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2023Estimated

Primary Completion Date

Jan 2024Estimated

Completion Date

Jan 2024Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 10, 2023

First Posted Date

Jan 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
blood tests	Other	evaluate the possible impact of iron oxide nanoparticles (superparamagnetic iron oxide = SPIONs) (N=10) in the blood circulation;	controls patients from intensive care units

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all people

Exclusion Criteria:

patient under 18 years old, legal protection measure, pregnancy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Leftover plasma sample from controls and patients hospitalized in CHU Dijon

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DE MAISTRE Emmanuel	Contact	380293257	+33	emmanuel.demaistre@chu-dijon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU DIJON BOURGOGNE - laboratoire mixte		Dijon		21000	France

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided