Ischemia Clinical Trial
— EWoDCIOfficial 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.
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; |
Country | Name | City | State |
---|---|---|---|
Lithuania | Vilnius University Hospital Santaros klinikos | Vilnius |
Lead Sponsor | Collaborator |
---|---|
Vilnius University | Kaunas University of Technology, Lithuanian University of Health Sciences |
Lithuania,
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 |
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