Comparing two methods for treating chronic subdural hematoma

YL-1 Needle Puncture Versus Burr-hole Craniotomy With Postoperative Exhaustive Drainage for Chronic Subdural Hematoma: a Multicenter Prospective Cohort Study

This study is testing two different surgical methods to see which one has fewer complications for adults with chronic subdural hematoma.

Quick facts

• Study type: Observational
• Enrollment: 460 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06072053 on ClinicalTrials.gov

What this trial studies

This multicenter observational study aims to compare the complications associated with YL-1 Needle Puncture and Burr Hole Craniostomy (BHC) with postoperative exhaustive drainage in patients suffering from chronic subdural hematoma. Chronic subdural hematoma is a condition that can lead to significant neurological dysfunction and requires surgical intervention. The study will evaluate the effectiveness and safety of these two surgical techniques to determine the optimal treatment strategy. Participants will be adults diagnosed with chronic subdural hematoma, and the study will involve rigorous data collection and analysis to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with preoperative neurological dysfunction and a confirmed diagnosis of chronic subdural hematoma.

Not a fit: Patients without symptoms or those whose condition does not require surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients with chronic subdural hematoma.

How similar studies have performed: While the approach of using YL-1 Needle Puncture is relatively novel, previous studies have indicated that less invasive techniques can reduce complications in similar surgical contexts.

Eligibility criteria

Inclusion Criteria:

1. Adults, male or female, 18 years ≤ age ≤ 90 years;
2. Preoperative neurological dysfunction, such as headache and dizziness, nausea and vomiting, limb numbness or weakness, unsteady walking, limb twitching, confusion, aphasia, slow response, memory loss, etc;
3. A definite diagnosis of chronic subdural hematoma by CT or MRI;
4. Signed informed consent.

Exclusion Criteria:

1. No symptoms before surgery and no obvious impact on oneself's normal life;
2. Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons;
3. Previous surgery for chronic subdural hematoma during the past 6 months;
4. Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before
5. Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed
6. Combination of major systemic diseases that are expected to interfere with study implementation and follow-up observations;
7. Definite coagulation abnormalities with a high risk of bleeding (presence of one of the following three: prolongation of the prothrombin time PT or the activated partial thromboplastin time APTT by more than 10 seconds, an international normalized ratio INR greater than 3.0, and an absolute platelet value of less than 100 × 109/L);
8. Postoperative cooperation is suspected to be insufficient for follow-up for 6 months;
9. Reproductive-age women without verified negative pregnancy testing;
10. Participating in other research

Where this trial is running

Beijing, Beijing

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Weiming Liu, M.D. — Beijing Tiantan Hospital
• Study coordinator: Weiming Liu, M.D.

Conditions: Chronic Subdural Hematoma, YL-1 Needle Drainage, Burr Hole Craniostomy, Exhaustive drainage strategy