An observational study in Chronic Subdural Hematoma, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-27.
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 11th registered.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 460 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.
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 cohort study was designed to compare the differences in complications with YL-1 Needle Puncture versus Bulr-hole Craniotomy (BHC) with postoperative Exhaustive Drainage strategy for patients with Chronic Subdural Hematoma.
Chronic subdural haematoma (CSDH) is a common condition in neurosurgery. It is generally considered to be a closed exudate formed by blood or blood degradation products between the dura mater and the arachnoid membrane. Its local occupying effect will compress the neighbouring brain tissues, leading to varying degrees of neurological dysfunction. In severe cases, it can lead to cerebral hernia and endanger the patient's life. Currently, the most commonly used surgical method for the treatment of chronic subdural haematoma is BHC, but many studies have found that various complications may occur after BHC. With the rapid development of neurosurgical microtechnology, Twist Drill Craniotomy (TDC) was proposed. YL-1 puncture needle technique, as a modified solution of TDC, has a short surgical time and is less traumatic to patients. In the treatment of chronic subdural haematomas, investigator's team has adopted the strategy of postoperative instillation of urokinase and adequate drainage of the haematoma. Based on this, this study intends to conduct a multicentre prospective observational cohort study of the above two treatment in order to scientifically and rigorously derive the optimal clinical treatment strategy for chronic subdural haematoma.
Patients with CSDH recruited from the neurosurgery departments of 12 medical centers in China who had significant clinical symptoms confirmed by computed tomography or magnetic resonance imaging. Six medical centers each used BHC as well as YL-1 puncture needles for comparison.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with CSDH recruited from the neurosurgery departments of 6 medical centers in China who had clinically significant symptoms confirmed by computed tomography or magnetic resonance imaging and ultimately treated with Bulr-hole Craniotomy.
Procedure: Burr Hole Craniostomy and Postoperative Exhaustive Drainage Strategy
Patients with CSDH recruited from the neurosurgery departments of 6 medical centers in China who had clinically significant symptoms confirmed by computed tomography or magnetic resonance imaging and ultimately treated with YL-1 needle puncture.
Procedure: YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy
According to the preoperative CT results, drilling and drainage was performed at the thickest level of the hematoma; during the operation, the hematoma cavity was adequately flushed with saline and a drainage tube was left in the hematoma cavity; after the operation, the hematoma cavity was flushed with urokinase, and the drainage tube was removed after adequate drainage.
Based on preoperative CT, the thickest level of the hematoma was selected and localized. During the operation, an electric drilling needle was used to rapidly break through the skull and dura to enter the cavity of the subdural hematoma, and the puncture needle was fixed to the skull to drain the subdural hematoma. After the operation, the hematoma cavity was flushed with urokinase, and the drainage tube was removed after adequate drainage.
Complication rates
To compare the difference in overall complication rates between the two groups of CSDH patients treated with YL-1 perforator needles and drilled drainage at 3 months postoperatively.
Time frame: From operation up to 3 months postoperatively
Recurrence rate
To compare the difference in recurrence rate at 3 months postoperatively between the two groups;
Time frame: From operation up to 3 months postoperatively
Mortality rate
To compare the difference in mortality rate at 3 months postoperatively between the two groups;
Time frame: From operation up to 3 months postoperatively
Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation
Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.
Time frame: At baseline and at 3 months after operation
Quality of life assessment (EQ-5D-5L)
A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'postoperatively between the two groups.
Time frame: At baseline and at 3 months after operation
Change of Markwalder Grading Scale between groups from baseline to 3 months after operation
Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.
Time frame: At baseline and at 3 months after operation
Hospitalization costs
To compare the difference in hospitalization costs between the two groups.
Time frame: At baseline.
Length of hospitalization
To compare the difference in length of hospitalization between the two groups;
Time frame: At baseline.
Plan to share: No
Started Dec 2023 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
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