Early Brain Damage Assessment in Aneurysmal Subarachnoid Haemorrhage in Predicting Cognitive Impairment

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

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.

Study Overview

• Status: Completed
• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Intervention / Treatment: Procedure: Endovascular coiling, Surgical clipping, Mix

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 Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 05000
      • The First Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Han Chinese emergency call

Description

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.

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Exclusion Criteria: 1) 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of subarachnoid blood on cranial CT	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	24 - 48 hours

Collaborators and Investigators

• Sponsor: Hebei Medical University
• Investigators: Principal Investigator: Mingdong Wang, The First Hospital of Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Intracranial Hemorrhages; Hemorrhage; Cognitive Dysfunction; Subarachnoid Hemorrhage
• Other Study ID Numbers: ID: 2023-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No