Subarachnoid Hemorrhage, AneurysmalEWoDCINCT06006975
Early Warning of Delayed Cerebral Ischemia
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Vasospasm, Cerebral, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Vasospasm, Cerebral, Ischemia
- What is being tested?
- Computed Tomography (CT) and Computed Tomography Angiography (CTA) and Multimodal physiological monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteLithuania
- Study dates
- 21 Sep 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subarachnoid hemorrhage patients who require SAH surgery and post-operative routine treatment.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros klinikos
Vilnius, 08661
Saulius Rocka, Prof. Dr., +37068743480, saulius.rocka@santa.lt
Aidanas Preiksaitis, Dr., +37065915104, danas911@gmail.com
About this study
Official title: 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.
Read the 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:
- 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
- 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.
- To perform retrospective analysis of other clinical data (blood test results), demographic data (gender, age) and their impact on development of CV and DCI.
- To develop the algorithm of predicting of CV, DCI and patients' outcome based on the accumulated neuroradiological examination and multimodal monitoring data.
- Being tested
- Computed Tomography (CT) and Computed Tomography Angiography (CTA), Multimodal physiological monitoring
- Keywords
- subarachnoid hemorrhage, delayed cerebral ischemia, computed tomography
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Multimodal physiological monitoringDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Subarachnoid hemorrhage (SAH) patients | Patients after aneurysmal subarachnoid hemorrhage who received routine treatment (aneurysm clipping surgery, post operative care and multimodal monitoring in ICU). Receives: Radiation: Computed Tomography (CT) and Computed Tomography Angiography (CTA); Diagnostic Test: Multimodal physiological monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral vasospasms
Cerebral vasospasms are diagnosed by performing Computed Tomography Angiography (CTA) according to reduced diameters of cerebral arteries.
Measured: 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)
Measured: 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
Measured: GOS is evaluated at discharge from hospital and after 30 days after SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start21 Sep 2021
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaunas University of Technology, Lithuanian University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Saulius Rocka, Prof. Dr., Principal investigator, Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006975
- Sponsor's protocol ID
- EWoDCI ver.C
- Other IDs
- 01.2.2-LMT-K-718-03-0091
- Acronym
- EWoDCI
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R&D of Innovative Technology for Predicting and Early Warning of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06006975
- Acronym / sponsor ID
- EWoDCI / EWoDCI ver.C
- Keywords
- subarachnoid hemorrhage, delayed cerebral ischemia, computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Kaunas University of Technology, Lithuanian University of Health Sciences
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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.
- To perform retrospective analysis of other clinical data (blood test results), demographic data (gender, age) and their impact on development of CV and DCI.
- To develop the algorithm of predicting of CV, DCI and patients' outcome based on the accumulated neuroradiological examination and multimodal monitoring data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid hemorrhage (SAH) patients | – | Radiation: Computed Tomography (CT) and Computed Tomography Angiography (CTA), Diagnostic Test: Multimodal physiological monitoringPatients after aneurysmal subarachnoid hemorrhage who received routine treatment (aneurysm clipping surgery, post operative care and multimodal monitoring in ICU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Subarachnoid hemorrhage patients who require SAH surgery and post-operative routine treatment.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Subarachnoid hemorrhage (SAH) patients |
| Multimodal physiological monitoringPatients 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. | Diagnostic test | Subarachnoid hemorrhage (SAH) patients |
Primary outcome
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.
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)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saulius Rocka, Prof. Dr. principal investigator
Clinic of Neurology and Neurosurgery, Faculty of Medicine, Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Vasospasm, Cerebral, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saulius Rocka, Prof. Dr. (+37068743480, saulius.rocka@santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral vasospasms (time frame: CTA is performed routinely on 7th day after SAH or within period of 3-21 day after SAH if necessary). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023; AzTrials last refreshed its copy on 3 Nov 2026.