NCT06069973

Brief Summary

The overall goal of this project is to determine if machine learning and analysis of neurospecific biomarkers can enable early detection of upcoming or ongoing cerebral ischaemia in patients suffering from subarachnoid haemorrhage with altered consciousness due to cerebral injury or sedation. Analyses of heart rate variability, electroencephalgraphy,nearinfrared spectroscopy, cerebral autoregulation, and brain injury specific biomarkers in blood and cerebrospinal fluid will be performed.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jan 2024Dec 2033

First Submitted

Initial submission to the registry

September 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

10 years

First QC Date

September 26, 2023

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Early warning system

    To develop a machine learning-based model that can identify patterns in signals obtained from HRV, NIRS, and EEG monitoring, which are consistent with upcoming cerebral ischemia and provide a warning about this to attending physicians. To define the specificity and time relation of neurospecific biomarkers in blood and cerebrospinal fluid in patients with subarachnoid haemorrhage with and without delayed cerebral ischemia to evaluate if any of these biomarkers can be used as an indicator for ongoing cerebral ischemia. To assess the prognostic value of changes in physiological and neurospecific biomarkers changes during the acute phase after subarachnoid hemorrhage on long-term outcome.

    2023-2033

  • Autoregulation

    xyz

    2023-2033

Study Arms (2)

Delayed cerebral ischemia

Definition by Vergouwen et al. Verified by computed tomography

Other: No intervention, observational study

Non-delayed cerebral ischemia

No signs of cerebral ischemia clinically or by computed tomography.

Other: No intervention, observational study

Interventions

No intervention

Delayed cerebral ischemiaNon-delayed cerebral ischemia

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult people with aneurysmal subarachnoid hemorrhage

You may qualify if:

  • Patients over the age of 18 with aneurysmal subarachnoid hemorrhage admitted to intensive care units at Sahlgrenska University hospital.

You may not qualify if:

  • Unable to consent,
  • Cardiac arrythmia,
  • Previous brain damage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Cerebrospinal fluid

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 6, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations