Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)
Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study
Beijing Tiantan Hospital
420 participants
Mar 13, 2023
OBSERVATIONAL
Conditions
Summary
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.
Eligibility
Inclusion Criteria7
- Case group (CSDH group)
- Patients (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
- 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 Criteria7
- Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before.
- 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.
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Interventions
Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.
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.
Collect peripheral blood samples from patients.
Collect urine and stool samples from patients.
Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05599217