Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

Capital Medical University

Status: Enrolling

Conditions: Chronic Subdural Hematoma

Treatments: Other: Metabonomic test; Other: Peripheral blood test; Other: Hematoma test; Other: Neurological function, cognitive function, and life quality assessment; Other: Dietary and nutritional questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT05599217

HX-B-2022062

Details and patient eligibility

About

A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.

Full description

Chronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions, which is considered to be an inflammatory disease. Dietary factors can have an impact on the inflammatory mechanism in human body, which can increase a variety of inflammatory biomarkers in the blood. The risk of malnutrition in the elderly is generally high, and nutritional status can affect the risk of CSDH in the elderly. Little is known about the association of dietary factors with CSDH. The investigators speculate that dietary factors participate in and promote the occurrence and development of CSDH. This study will clarify whether there is a correlation between dietary factors and CSDH, which will reveal the pathogenesis and prevention of CSDH.

Enrollment: 420 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Case group (CSDH group)

Inclusion Criteria:

• 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)

Inclusion Criteria:

• 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 for both case and control group:

• 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.

Trial design

420 participants in 2 patient groups

Case group (CSDH group)

Description:

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.

Treatment:

Other: Dietary and nutritional questionnaire

Other: Metabonomic test

Other: Neurological function, cognitive function, and life quality assessment

Other: Peripheral blood test

Other: Hematoma test

Control group (Healthy group)

Description:

non-CSDH, age- and gender-matched patients recruited from ophthalmology, otolaryngology, and physical examination department at 4 medical centres in China.

Treatment:

Other: Dietary and nutritional questionnaire

Other: Metabonomic test

Other: Peripheral blood test