Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)
NCT ID: NCT05599217
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
420 participants
OBSERVATIONAL
2023-03-13
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case group (CSDH group)
CSDH patients recruited from neurosurgical department at 4 medical centres in China, which have apparent clinical symptoms and are confirmed by computed tomography or magnetic resonance imaging.
Dietary and nutritional questionnaire
Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.
Neurological function, cognitive function, and life quality assessment
Neurological function, cognitive function, and life quality will be examined using Glasgow Coma Scale, Modified Rankin Scale, Markwalder Grade Scale, Mini-mental state examination, and EuroQol five dimensions questionnaire.
Peripheral blood test
Collect peripheral blood samples from patients.
Metabonomic test
Collect urine and stool samples from patients.
Hematoma test
Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.
Control group (Healthy group)
non-CSDH, age- and gender-matched patients recruited from ophthalmology, otolaryngology, and physical examination department at 4 medical centres in China.
Dietary and nutritional questionnaire
Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.
Peripheral blood test
Collect peripheral blood samples from patients.
Metabonomic test
Collect urine and stool samples from patients.
Interventions
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Dietary and nutritional questionnaire
Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.
Neurological function, cognitive function, and life quality assessment
Neurological function, cognitive function, and life quality will be examined using Glasgow Coma Scale, Modified Rankin Scale, Markwalder Grade Scale, Mini-mental state examination, and EuroQol five dimensions questionnaire.
Peripheral blood test
Collect peripheral blood samples from patients.
Metabonomic test
Collect urine and stool samples from patients.
Hematoma test
Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.
Eligibility Criteria
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Inclusion Criteria
* CSDH verified on cranial computed tomography or magnetic resonance imaging.
* Written informed consent from patients or their next of kin according to the patient's cognitive status.
Control group (Healthy group)
* non-CSDH patients (18 years to 90 years) with matched age and gender.
* Written informed consent from patients or their next of kin according to the patient's cognitive status.
Exclusion Criteria
* CSDH turned from acute subdural hematoma.
* Existing malignant tumors, poor medication condition or severe comorbidity.
* Difficulty in feeding requiring long-term enteral or parenteral nutrition support.
* Dietary and nutritional survey is estimated to be completed difficultly.
* Reproductive-age women without verified negative pregnancy testing.
* Participating in other research.
18 Years
90 Years
ALL
Yes
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Weiming Liu
Professor
Principal Investigators
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Weiming Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Huangshan City People's Hospital
Huangshan City, Anhui, China
First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Zhaofeng Zhang, Ph.D.
Role: CONTACT
Facility Contacts
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Other Identifiers
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HX-B-2022062
Identifier Type: -
Identifier Source: org_study_id
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