NFL Dynamics as a Predictor Factor in Patients With Out o... | NCT05218278

Studies
NFL Dynamics as a Predictor Factor in Patients With Out of Hospital Cardiac Arrest

NCT05218278

Sponsor

University Medical Centre Maribor

Status

Recruiting

Last Update Posted

Mar 30, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Out-Of-Hospital Cardiac Arrest
Neurological Injury

Interventions

Not provided

Countries

Slovenia

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 17, 2022

First Submission Date that Met QC Criteria

Jan 29, 2022

First Posted Date

Feb 1, 2022Actual

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

Mar 25, 2025

Last Update Posted Date

Mar 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matej Strnad, Associate Proffessor, University Medical Centre MariborPrincipal Investigator

Lead Sponsor

University Medical Centre MariborOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To investigate the pharmacodynamics of light chain of NFL in patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.

Detailed Description

To investigate the serum levels of the light chain of NFL at different time points after ICU admission (12, 24, 30, 36, 42, 48 hours after ICU admission) patients with out-of hospital cardiac arrest after successful resuscitation and determine the difference in the serum levels of NFL in patients with favorable neurological outcome compared to those with non-favorable neurological outcome.

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 with favorable neurlogical outcome		CPC 1/2
Patients with non-favorable neurological outcome		CPC3-5

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference in the dynamics of serum NFL levels measurements in patients with favorable neurological outcome compared to patients with non-favorable neurological outcome	NFL levels	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU

Exclusion Criteria:

trauma, drowning, electrocution, less than 18 years of age,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with non-traumatic out-of-hospital cardiac arrest successfully resuscitated and admitted to the ICU.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matej Strnad, MD, PhD	Contact	+38651225448		strnad.matej78@gmail.com

Overall Officials

Name	Affiliation	Role
Matej Strnad, MD, PhD	University medical cenetr Maribor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University medical center Maribor	Recruiting	Maribor		2000	Slovenia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD that underlie results in a publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058687	Out-of-Hospital Cardiac Arrest
D020196	Trauma, Nervous System

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided