Early Warning of Delayed Cerebral Ischemia (EWoDCI)

August 31, 2023 updated by: Vilnius University

R&D of Innovative Technology for Predicting and Early Warning of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An adequate timely prognosis of cerebral vasospasms and delayed cerebral ischemia (DCI) occuring after spontaneous aneurysmal subarachnoid haemorrhage (aSAH), is vitally essential to selecting an individualized and timely treatment strategy. Cerebral vasospasms (CV) occur in up to 70% of aSAH cases, and in two thirds of those cases DCI develops, thus increasing the mortality rate up to 50%. Every year up to 770 000 people suffer from aSAH and receive neurosurgical treatment. Because of a large amount of factors (blood leak volume and its distribution in the subarachnoid space, reactivity of cerebral blood vessels, biochemical blood composition and demographical factors) and their complex interactions to contribute the development of CV/DCI, currently there are no reliable methods and technologies allowing reliably prediction of the consequences of SAH.

For a more effective treatment of aSAH patients an innovative method for early warning of CV and DCI phenomena is offered. The method is based on identifying of the associations of different physiological modalities and prognostic factors with the SAH patients' outcome (factors the obtained from CT images analysis, numerical modelling of SAH evolution and multimodal cerebral hemodynamics monitoring).

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.) into development of cerebral vasospasms, delayed cerebral ischemia.

Study objectives:

  1. To perform retrospective analysis neuroradiological examination data (CT/CTA images) of patients who experienced spontaneous aSAH, by identifying factors that allow early prediction of CV and DCI
  2. To perform retrospective analysis of the collected data of multimodal brain physiological monitoring (intracranial pressure, arterial blood pressure, cerebral blood flow velocity, heart rate) by determining the factors that allow to predict CV and DCI.
  3. To perform retrospective analysis of other clinical data (blood test results), demographic data (gender, age) and their impact on development of CV and DCI.
  4. To develop the algorithm of predicting of CV, DCI and patients' outcome based on the accumulated neuroradiological examination and multimodal monitoring data.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Lithuania
      • Vilnius, Lithuania, 08661
        • Recruiting
        • Vilnius University Hospital Santaros Klinikos
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
CT and CTA examinations are performed as a routine procedure to evaluate SAH severity and to diagnose cerebral vasospams and delayed cerebral ischemia.
Diagnostic test: Multimodal physiological monitoring

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral vasospasms
Time Frame: CTA is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary
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
Time Frame: CT is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary
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
Time Frame: GOS is evaluated at discharge from hospital and after 30 days after SAH
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Collaborators

Lithuanian University of Health Sciences
Kaunas University of Technology

Investigators

  • Principal Investigator: Saulius Rocka, Prof. Dr., Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EWoDCI ver.C
  • 01.2.2-LMT-K-718-03-0091 (Other Grant/Funding Number: Research Council of Lithuania)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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