Aneurysmal Subarachnoid HemorrhageNCT06172556
Early Brain Damage Assessment in Aneurysmal Subarachnoid Haemorrhage in Predicting Cognitive Impairment
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Endovascular coiling, Surgical clipping, Mix
- Type of treatment
- Surgery or procedure
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Han Chinese emergency call
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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 05000
About this study
Official title: 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.
Read the 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).
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Endovascular coiling, Surgical clipping, Mix
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular coiling, Surgical clipping, MixProcedure or surgery
Endovascular coiling, Surgical clipping, Mix
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 - 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Mingdong, MD, Hebei Medical University
- Investigators
- Mingdong Wang, Principal investigator, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172556
- Sponsor's protocol ID
- ID: 2023-1001
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang MD, Fu QH, Ni A, Yuan YP, Li CH, Wang ZX, Wang H. The role of early cerebral edema and hematoma assessment in aneurysmal subarachnoid hemorrhage (a-SAH) in predicting early brain injury (EBI) and cognitive impairment: a case controlled study. Int J Surg. 2024 Jun 1;110(6):3166-3177. doi: 10.1097/JS9.0000000000001244.
PubMed 38445521
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Early Cerebral Edema and Hematoma Assessment in Aneurysmal Subarachnoid Hemorrhage (a-SAH) in Predicting Structural Brain Abnormalities in Cognitive Impairments
- ClinicalTrials.gov ID
- NCT06172556
- Acronym / sponsor ID
- ID: 2023-1001
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Han Chinese emergency call
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular coiling, Surgical clipping, MixEndovascular coiling, Surgical clipping, Mix | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 38445521Wang MD, Fu QH, Ni A, Yuan YP, Li CH, Wang ZX, Wang H. The role of early cerebral edema and hematoma assessment in aneurysmal subarachnoid hemorrhage (a-SAH) in predicting early brain injury (EBI) and cognitive impairment: a case controlled study. Int J Surg. 2024 Jun 1;110(6):3166-3177. doi: 10.1097/JS9.0000000000001244.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingdong Wang principal investigator
The First Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of subarachnoid blood on cranial CT (time frame: 24 - 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.