YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH
NCT ID: NCT06072053
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
460 participants
OBSERVATIONAL
2023-12-22
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BHC group
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.
Burr Hole Craniostomy 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.
YL-1 Needle Puncture group
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.
YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy
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.
Interventions
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Burr Hole Craniostomy 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.
YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
90 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Weiming Liu
Professor
Principal Investigators
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Weiming Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Weiming Liu, MD
Role: primary
References
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Almenawer SA, Farrokhyar F, Hong C, Alhazzani W, Manoranjan B, Yarascavitch B, Arjmand P, Baronia B, Reddy K, Murty N, Singh S. Chronic subdural hematoma management: a systematic review and meta-analysis of 34,829 patients. Ann Surg. 2014 Mar;259(3):449-57. doi: 10.1097/SLA.0000000000000255.
Brennan PM, Kolias AG, Joannides AJ, Shapey J, Marcus HJ, Gregson BA, Grover PJ, Hutchinson PJ, Coulter IC; British Neurosurgical Trainee Research Collaborative. The management and outcome for patients with chronic subdural hematoma: a prospective, multicenter, observational cohort study in the United Kingdom. J Neurosurg. 2017 Mar 17:1-8. doi: 10.3171/2016.8.JNS16134.test. Online ahead of print.
Duerinck J, Van Der Veken J, Schuind S, Van Calenbergh F, van Loon J, Du Four S, Debacker S, Costa E, Raftopoulos C, De Witte O, Cools W, Buyl R, Van Velthoven V, D'Haens J, Bruneau M. Randomized Trial Comparing Burr Hole Craniostomy, Minicraniotomy, and Twist Drill Craniostomy for Treatment of Chronic Subdural Hematoma. Neurosurgery. 2022 Aug 1;91(2):304-311. doi: 10.1227/neu.0000000000001997. Epub 2022 May 24.
Kolias AG, Chari A, Santarius T, Hutchinson PJ. Chronic subdural haematoma: modern management and emerging therapies. Nat Rev Neurol. 2014 Oct;10(10):570-8. doi: 10.1038/nrneurol.2014.163. Epub 2014 Sep 16.
Lee SJ, Hwang SC, Im SB. Twist-Drill or Burr Hole Craniostomy for Draining Chronic Subdural Hematomas: How to Choose It for Chronic Subdural Hematoma Drainage. Korean J Neurotrauma. 2016 Oct;12(2):107-111. doi: 10.13004/kjnt.2016.12.2.107. Epub 2016 Oct 31.
Other Identifiers
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HX-B-2023035
Identifier Type: -
Identifier Source: org_study_id