Early Warning of Delayed Cerebral Ischemia

Ischemia Clinical Trial

— EWoDCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006975
• Other study ID #: EWoDCI ver.C
• Secondary ID: 01.2.2-LMT-K-718
• Status: Recruiting
• Start date: September 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Vilnius University
• Contact: Saulius Rocka, Prof. Dr.
• Phone: +37068743480
• Email: saulius.rocka[@]santa.lt
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Hemorrhage
• Ischemia
• Outcome, Fatal
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal
• Vasospasm, Cerebral
• Vasospasm, Intracranial

Intervention

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.

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros klinikos	Vilnius

Sponsors (3)

Lead Sponsor	Collaborator
Vilnius University	Kaunas University of Technology, Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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