White Cell Ratios as Markers of Delirium and Outcome in A... | NCT03944694

Studies
White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke.

NCT03944694

Sponsor

Pomeranian Medical University Szczecin

Status

Completed

Last Update Posted

May 10, 2019Actual

Enrollment

1,001Actual

Phase

Not provided

Conditions

Delirium
Ischemic Stroke

Interventions

Delirium assessment.

Countries

Not provided

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

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2015Actual

Primary Completion Date

Mar 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

May 8, 2019

First Submission Date that Met QC Criteria

May 8, 2019

First Posted Date

May 9, 2019Actual

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

May 8, 2019

Last Update Posted Date

May 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katarzyna Kotfis, Principal Investigator, Pomeranian Medical University SzczecinPrincipal Investigator

Lead Sponsor

Pomeranian Medical University SzczecinOTHER

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

The aim of this study was to investigate the role of Neutrophil-to-Lymphocyte Ratio (NLR) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (AIS).

Detailed Description

Delirium is an acute brain disorder, potentially reversible, commonly occurring in patients with acute ischemic stroke. The pathomechanism of delirium is related to neuroinflammatory process and oxidative stress. Search for readily available diagnostic marker that will aid clinicians in early identification of delirium is an on-going process. The aim of this study was to investigate the role of Neutrophil-to-Lymphocyte Ratio (NLR) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (AIS).

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

1,001Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Delirious		Patients were delirious if CAM-ICU was positive within 24 hours from admission due to acute ischemic stroke.	Diagnostic Test: Delirium assessment.
Non-delirious		Patients were delirious if CAM-ICU was negative within 24 hours from admission due to acute ischemic stroke.	Diagnostic Test: Delirium assessment.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Delirium assessment.	Diagnostic Test	Full blood count analysis.	Delirious Non-delirious

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early-onset-delirium.	Delirium within 24 hours from admission.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Mortality at 30 days.	Mortality determined at follow-up on day 30 after acute ischemic stroke.	30 days
Mortality at 1 year.	Mortality determined at follow-up at 1 year after acute ischemic stroke.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >18 years)
acute ischemic stroke

Exclusion Criteria:

hematology disorders
incomplete laboratory testing
no data regarding follow-up

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

Consecutive adult patients (age >18 years) with acute ischemic stroke, admitted to a neurology department of a busy district general hospital in Poland between 30.06.2015 and 31.03.2018. Patients with AIS were admitted to the neurology department within 48 hours of symptom development.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iwona Rotter, MD, PhD	Pomeranian Medical University Szczecin	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D000083242	Ischemic Stroke
D020521	Stroke

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided