Risk Factors and Outcomes in Patients Treated in Neurocri... | NCT07052656

Studies
Risk Factors and Outcomes in Patients Treated in Neurocritical Care

NCT07052656

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Jul 10, 2025Actual

Enrollment

70,000Actual

Phase

Not provided

Conditions

Neuro-intensive Care Unit Patients
Subarachnoid Hemorrhage, Aneurysmal
Ischemic Stroke
Intracerebral Hemorrhage
Stroke, Acute
Meningitis
Epilepsy
Traumatic Brain Injury
Acute Brain Injuries
Acute Neurological Injury

Interventions

Observational study, participants are not assigned an intervention as part of the study.
Transport modality

Countries

Sweden

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

ID	Type	Description	Link
KI: 4-1998/2022	Other Identifier	Karolinska Institutet

Status Module

Record Verification Date

Jul 2025

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

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

May 28, 2025

First Submission Date that Met QC Criteria

Jul 1, 2025

First Posted Date

Jul 4, 2025Actual

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

Jul 4, 2025

Last Update Posted Date

Jul 10, 2025Actual

Name	Class
Karolinska University Hospital	OTHER

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 overall purpose of this epidemiologic research project is to provide a comprehensive exploration and analysis of critical elements within the neuro-intensive care process in Sweden. All aspects of intensive care management in critically ill patients with acute brain injury will be addressed. The analyses include description of patient characteristics, intensive care data, management and treatments, various aspects of short and long-term follow-up, mortality, regional- and sex-related differences. The long-term goal is to develop neuro-intensive care and management, to minimize in-hospital insults and secondary injuries, to improve diagnostics and follow-up, in order to reduce prolonged neurologic deficits and mortality in these patients.

Detailed Description

Not provided

Conditions Module

Conditions

Neuro-intensive Care Unit Patients
Subarachnoid Hemorrhage, Aneurysmal
Ischemic Stroke
Intracerebral Hemorrhage
Stroke, Acute
Meningitis
Epilepsy
Traumatic Brain Injury
Acute Brain Injuries
Acute Neurological Injury

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuro-intensive care patients			Other: Observational study, participants are not assigned an intervention as part of the study. Other: Transport modality

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational study, participants are not assigned an intervention as part of the study.	Other	Observational study, participants are not assigned an intervention as part of the study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality	Up to two years

Secondary Outcomes

Measure	Description	Time Frame
Morbidity	Neuropsychiatric diagnoses, depression/anxiety), longterm sick leave, loss of income as a proxy for quality of life	Up to two years

Other Outcomes

Measure	Description	Time Frame
DAOH90	Days alive and out of hospital	90 days
Complications	Rebleeding, secondary insults, cerebral infarctions	90 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU admission 2010 to 2024
Clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage or ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalititis or other brain injury diagnosis.

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

All patients 18 years or older treated in an ICU in Sweden with a clinical diagnosis of subarachnoid hemorrhage, intracranial hemorrhage, ischemic brain injury, traumatic brain injury, epilepsy, meningitis, encefalitis or other brain injury diagnosis from 2010 to 2024.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linn Hallqvist, MD, PhD	Dep of Perioperative Medicine and Intensive care, Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Stockholm			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D013345	Subarachnoid Hemorrhage
D000083242	Ischemic Stroke
D002543	Cerebral Hemorrhage
D020521	Stroke
D008581	Meningitis
D004827	Epilepsy
D000070642	Brain Injuries, Traumatic
D001930	Brain Injuries

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006470	Hemorrhage
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000090862	Neuroinflammatory Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D014947	Wounds and Injuries

ID	Term
D008722	Methods
D008919	Investigative Techniques