YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH

Launched by BEIJING TIANTAN HOSPITAL · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two different surgical methods for treating Chronic Subdural Hematoma, which is a condition where blood pools between the brain and its outer covering, often causing symptoms like headaches, dizziness, and confusion. The study will look at the safety and complications of using a special needle (called YL-1 Needle Puncture) versus a more traditional method known as Burr-hole Craniotomy (BHC) followed by thorough drainage after surgery. This trial is currently recruiting participants, and it is open to adults aged 18 to 90 who have been diagnosed with this condition and show neurological symptoms.

To be eligible for this trial, participants need to have noticeable symptoms affecting their daily life and a confirmed diagnosis through imaging tests like CT or MRI. However, individuals without symptoms, those who have had recent surgeries for the same condition, or those with serious health issues that could complicate surgery or follow-up care will not be included. Participants can expect to receive either of the surgical treatments and will be monitored for any complications following the procedure. This study is important as it aims to find out which method may lead to better outcomes for patients suffering from Chronic Subdural Hematoma.

Gender

ALL

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