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Clinical Trials/NCT06172556
NCT06172556CompletedNot Applicable

The Role of Early Cerebral Edema and Hematoma Assessment in Aneurysmal Subarachnoid Hemorrhage (a-SAH) in Predicting Structural Brain Abnormalities in Cognitive Impairments

Hebei Medical University1 site in 1 country202 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
202
Locations
1
Primary Endpoint
Description of subarachnoid blood on cranial CT

Study Overview

Brief Summary

the goal of this type of study : observation study is to learn about cerebral edema and hematoma in aneurysmal subarachnoid hemorrhage the main questions it aims to answer are current clinical practices lack predictive models to identify early structural brain abnormalities affecting cognition.

Detailed Description

the development of a predictive model termed the a-SAH Early Brain Edema/Hematoma Compression Neural (Structural Brain) Networks Score System (SEBE-HCNNSS).

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • first-ever stroke, diagnosed with SAH via CT scan within 24 - 48 hours or lumbar puncture; 2) age between 18 and 70 years; 3) Confirmation of cerebral aneurysm by digital subtraction angiography (DSA) and/or CT angiography (CTA); 4) absence of neurological or psychiatric disease history and each unruptured intracranial aneurysm patient must be admitted to the hospital in excellent preoperative and pre-interventional condition; 5) Informed consent is signed by the patient and/or family. 6)Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets.

Exclusion Criteria

  • patients over 70 years old; 2) presence of neurological focal deficits or severe aphasia; 3) cognitive dysfunction or history of cognitive decline including craniotomy, antipsychotics, neurodegenerative diseases, and chronic subdural hematoma; 4) concurrent acute or chronic infections, corneal or pupillary abnormalities, severe autoimmune or systemic diseases such as rheumatic illnesses of the musculoskeletal system; 5) concurrent severe organic dysfunction; 6) patients with recurrent aneurysms or aneurysms not first diagnosed in our hospital; 7) diagnosis of major psychosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria 8)Insulin dependent diabetes,9)Thyroid disease

Outcomes

Primary Outcomes

Description of subarachnoid blood on cranial CT

Time Frame: 24 - 48 hours

No visible blood, no effacement, and no widening of the longitudinal fissure of the brain. Absence of visible sulci due to effacement, diffuse deposits, or thin layers of blood at specified brain locations (L-FPN or D-FPN or M-FPN or PN or ON or M-CIN or other), or widening of the longitudinal fissure. Localized/diffuse blood deposits (\<1 mm thick) at specified locations (L-FPN or D-FPN or M-FPN or PN or ON or M-CIN or other) in each section, without visible sulci in those areas at two predetermined levels in each hemisphere. For specified locations (L-FPN or D-FPN or M-FPN or PN or ON or M-CIN or other) in each section, absence of visible sulci at two predetermined levels in each hemisphere or disruption of the grey-white matter junction, with blood pooling (\<1 mm thick) in ventricles or cerebral pools (insular pools, circumferential pools, lateral fissure pools, interpeduncular pools, lateral ventricles). Disappearance of sulci at two predetermined levels in each hemisphere or local

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wang Mingdong, MD

Associate Professor, Associate Chief Physician

Hebei Medical University

Study Sites (1)

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