Early Warning of Delayed Cerebral Ischemia

NCT06006975 | Unknown

• 2 other identifiers: EWoDCI ver.C01.2.2-LMT-K-718-03-0091
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the possibility to predict clinical course of subarachnoid hemorrhage (SAH) patients by performing the retrospective analysis of clinical data available in early pre-vasospasm phase. The main questions it aims to answer are:

• What biomarkers retrieved from Computed Tomography (CT) and Computed Tomography Angiography (SAH location, leaked blood volume, cerebrospinal fluid volume, etc.) can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome.
• What biomarkers retrieved from transcranial Doppler examinations in early pre vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome.
• What biomarkers retrieved from multimodal physiological monitoring in early pre vasospasm can be used to predict development of cerebral vasospasms, delayed cerebral ischemia and patients' outcome.
• What is impact of other clinical data (blood test results, age, gender, etc.) on development of cerebral vasospasms and delayed cerebral ischemia.

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Vasospasm, Cerebral; Ischemia; Outcome, Fatal

Keywords

subarachnoid hemorrhage; delayed cerebral ischemia; computed tomography

Outcome Measures

Primary Outcomes (3)

• Cerebral vasospasms

  Cerebral vasospasms are diagnosed by performing Computed Tomography Angiography (CTA) according to reduced diameters of cerebral arteries.

  CTA is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary

• Delayed cerebral ischemia

  Delayed cerebral ischemia is diagnosed by performing Computed Tomography (CT)

  CT is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary

• Patient outcome

  Patients' outcome is evaluated according to Glasgow Outcome Score (GOS). GOS scores are: 1 - death, 2 - persistent vegetative state, 3 - severe disability, 4 - moderate disability, 5 - low disability

  GOS is evaluated at discharge from hospital and after 30 days after SAH

Study Arms (1)

Subarachnoid hemorrhage (SAH) patients

Patients after aneurysmal subarachnoid hemorrhage who received routine treatment (aneurysm clipping surgery, post operative care and multimodal monitoring in ICU).

Radiation: Computed Tomography (CT) and Computed Tomography Angiography (CTA); Diagnostic Test: Multimodal physiological monitoring

Interventions

Computed Tomography (CT) and Computed Tomography Angiography (CTA) RADIATION

CT and CTA examinations are performed as a routine procedure to evaluate SAH severity and to diagnose cerebral vasospams and delayed cerebral ischemia.

Subarachnoid hemorrhage (SAH) patients

Multimodal physiological monitoring DIAGNOSTIC_TEST

Patients are monitored routinely during their treatment in ICU. Multimodal physiological monitoring include continuous monitoring of arterial blood pressure (ABP), intracranial pressure (ICP) (if available), ETCO2 (if available), cerebral perfusion pressure (if available), cerebral blood flow velocity (CBFV) measured in middle cerebral artery and heart rate. Non invasive CBFV will be measured by using TCD device DWL Multi Dop-T. Invasive ICP will be measured by using Codman ICP Express or Raumedic ICP monitor.

Subarachnoid hemorrhage (SAH) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients treated at Vilnius University Hospital Santaros Klinikos that undergo brain surgery after subarachnoid hemorrhage (SAH) and routine post-operative treatment in ICU.

You may qualify if:

• Subarachnoid hemorrhage patients who require SAH surgery and post-operative routine treatment.

You may not qualify if:

• persons with mental disorders, but who can give consent to participate in biomedical research;
• minors;
• students, if their participation in biomedical research is related to studies;
• persons living in care institutions;
• soldiers during their actual military service;
• employees of health care institutions where biomedical research is conducted, subordinate to the researcher;

Sponsors & Collaborators

• Vilnius University: lead
• Kaunas University of Technology: collaborator
• Lithuanian University of Health Sciences: collaborator

Study Sites (1)

Vilnius University Hospital Santaros klinikos

Vilnius, 08661, Lithuania

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Ischemia

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saulius Rocka, Prof. Dr.

  Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saulius Rocka, Prof. Dr.

CONTACT

+37068743480; saulius.rocka@santa.lt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 21, 2021
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)