Status:
UNKNOWN
YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18-90 years
Brief 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 strat...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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);
- Postoperative cooperation is suspected to be insufficient for follow-up for 6 months;
- Reproductive-age women without verified negative pregnancy testing;
- Participating in other research
Key Trial Info
Start Date :
December 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT06072053
Start Date
December 22 2023
End Date
May 1 2025
Last Update
December 27 2023
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070