An observational study in Chronic Subdural Hematoma, sponsored by Beijing Tiantan Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Beijing Tiantan Hospital · Observational
Among 17 studies in Hematoma, Subdural, Chronic with a site in China — 9 open to participants now, 9 under way, none of them phase 3. Hematoma, Subdural, Chronic · China.
Among the 17 studies in Hematoma, Subdural, Chronic with a site in China, this one is one of 2 that started in 2023, is one of 2 observational ones, and was the 9th registered.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 420 is above the median of 210 across 20 observational studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →9 of the 17 studies in Hematoma, Subdural, Chronic with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 35 Hematoma, Subdural, Chronic studies recruiting now, 26 (74%) set no upper age limit and 1 (3%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2023.
Median enrollment 200 across the 15 interventional studies, 440 across the 2 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
1 of 17 have an industry lead sponsor. The 9 most frequent:
Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
Beijing Tiantan Hospital has 6 studies filed under Hematoma, Subdural, Chronic — fewer than ten, so there is no comparison to draw.
2 of the studies in Hematoma, Subdural, Chronic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06401772Huashan HospitalThe Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma | 2026-12 |
| NCT07144423Beijing Tiantan HospitalNeuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma | 2027-07-31 |
Among the 17 studies in Hematoma, Subdural, Chronic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.
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.
CSDH patients and non-CSDH, age- and gender-matched patients recruited from 4 medical centres in China.
Case group (CSDH group)
Inclusion Criteria:
Control group (Healthy group)
Inclusion Criteria:
Exclusion Criteria for both case and control group:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Dietary and nutritional questionnaire · Other: Neurological function, cognitive function, and life quality assessment · Other: Peripheral blood test · Other: Metabonomic test · Other: Hematoma test
non-CSDH, age- and gender-matched patients recruited from ophthalmology, otolaryngology, and physical examination department at 4 medical centres in China.
Other: Dietary and nutritional questionnaire · Other: Peripheral blood test · Other: Metabonomic test
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.
Difference in dietary intakes
Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies.
Time frame: When subjects are enrolled
Difference in Dietary Inflammatory Index score
The Dietary Inflammatory Index (DII) score of the current nutritional status of patients with and without CSDH will be evaluated. The amounts of nutrients will be calculated using last 3-month nutrient analysis program. DII score will calculate from these foods. The z-score must first be calculated. To calculate the z-score, the standard global consumption amount is subtracted from the average consumption amount of the individual. The result obtained is divided by the standard deviation value. The z score found with this result is converted to the percentile score. The percentile value is multiplied by the full inflammatory effect score. DII is obtained as a result of summing the scores calculated for all nutrients. Found DII is an indicator of the inflammatory load of the individual's daily diet.
Time frame: When subjects are enrolled
Difference in nutritional status
Difference in nutritional status measured by Mini-Nutritional Assessment.
Time frame: When subjects are enrolled
Difference in frailty status
Difference in frailty status measured by Modified Frailty Index. Modified Frailty Index ranges from score 0 to 1, and frail status is defined as a score of ≥0.27.
Time frame: When subjects are enrolled
Difference in gut microbiota measured by 16S rRNA between case group and control group
Fecal sample will be measured by 16S rRNA sequencing. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample. The PCA, PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.
Time frame: When subjects are enrolled
Difference in metabolomics of gut, urine, and serum between case group and control group
Changes of metabolites in gut, urine, and serum will be measured by metabolomic mass spectrometry.
Time frame: When subjects are enrolled
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2024, 21 months after the start.
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