R&D of Innovative Technology for Predicting and Early Warning of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Vilnius University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Cerebral vasospasms
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •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;
Outcomes
Primary Outcomes
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.
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
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)
Secondary Outcomes
No secondary outcomes reported