Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

NCT ID: NCT05599217

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-13

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Subdural Hematoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type OTHER

Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.

Neurological function, cognitive function, and life quality assessment

Intervention Type OTHER

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

Intervention Type OTHER

Collect peripheral blood samples from patients.

Metabonomic test

Intervention Type OTHER

Collect urine and stool samples from patients.

Hematoma test

Intervention Type OTHER

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

Intervention Type OTHER

Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.

Peripheral blood test

Intervention Type OTHER

Collect peripheral blood samples from patients.

Metabonomic test

Intervention Type OTHER

Collect urine and stool samples from patients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary and nutritional questionnaire

Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.

Intervention Type OTHER

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.

Intervention Type OTHER

Peripheral blood test

Collect peripheral blood samples from patients.

Intervention Type OTHER

Metabonomic test

Collect urine and stool samples from patients.

Intervention Type OTHER

Hematoma test

Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)


* 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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Weiming Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Weiming Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Huangshan City People's Hospital

Huangshan City, Anhui, China

Site Status RECRUITING

First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Site Status RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Site Status RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Liang Wu, M.D.

Role: CONTACT

15001333582 ext. +86

Zhaofeng Zhang, Ph.D.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jianbo Fang, M.D.

Role: primary

15105590826 ext. +86

Hui Zhou, M.D.

Role: primary

18961326536 ext. +86

Liang Wu, M.D.

Role: primary

+8615001333582

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HX-B-2022062

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Does What You Eat Affect Your Brain
NCT05626907 COMPLETED NA
PET Imaging of DHA Metabolism
NCT00074503 COMPLETED