NCT03944694

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

3.8 years

First QC Date

May 8, 2019

Last Update Submit

May 8, 2019

Conditions

DeliriumIschemic Stroke

Keywords

deliriumstrokeneutrophil-to-lymphocyte ratioNLRmortality

Outcome Measures

Primary Outcomes (1)

  • Early-onset-delirium.

    Delirium within 24 hours from admission.

    24 hours

Secondary Outcomes (2)

  • Mortality at 30 days.

    30 days

  • Mortality at 1 year.

    1 year

Study Arms (2)

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

Delirium assessment.DIAGNOSTIC_TEST

Full blood count analysis.

DeliriousNon-delirious

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • age \>18 years)
  • acute ischemic stroke

You may not qualify if:

  • hematology disorders
  • incomplete laboratory testing
  • no data regarding follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DeliriumIschemic StrokeStroke

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Iwona Rotter, MD, PhD

    Pomeranian Medical University Szczecin

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 9, 2019

Study Start

June 30, 2015

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share