YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH (NCT06072053) | Clinical Trial Compass
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YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH
China460 participantsStarted 2023-12-22
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Adults, male or female, 18 years ≤ age ≤ 90 years;
✓. 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;
✓. A definite diagnosis of chronic subdural hematoma by CT or MRI;
✓. Signed informed consent.
Exclusion criteria
✕. No symptoms before surgery and no obvious impact on oneself's normal life;
✕. Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons;
✕. Previous surgery for chronic subdural hematoma during the past 6 months;
✕. Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before
✕. Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed
✕. Combination of major systemic diseases that are expected to interfere with study implementation and follow-up observations;
✕. 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);
What they're measuring
1
Complication rates
Timeframe: From operation up to 3 months postoperatively