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

Chronic Subdural Hematoma Clinical Trial

— NEBULA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072053
• Other study ID #: HX-B-2023035
• Status: Recruiting
• Start date: December 22, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: December 2023
• Source: Beijing Tiantan Hospital
• Contact: Weiming Liu, M.D.
• Phone: 13701182770
• Email: liuweimingnsok[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 arachnoid membrane. Its local occupying effect will compress the neighbouring brain tissues, leading to varying degrees of neurological dysfunction. In severe cases, it can lead to cerebral hernia and endanger the patient's life. Currently, the most commonly used surgical method for the treatment of chronic subdural haematoma is BHC, but many studies have found that various complications may occur after BHC. With the rapid development of neurosurgical microtechnology, Twist Drill Craniotomy (TDC) was proposed. YL-1 puncture needle technique, as a modified solution of TDC, has a short surgical time and is less traumatic to patients. In the treatment of chronic subdural haematomas, investigator's team has adopted the strategy of postoperative instillation of urokinase and adequate drainage of the haematoma. Based on this, this study intends to conduct a multicentre prospective observational cohort study of the above two treatment in order to scientifically and rigorously derive the optimal clinical treatment strategy for chronic subdural haematoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: May 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rates	To compare the difference in overall complication rates between the two groups of CSDH patients treated with YL-1 perforator needles and drilled drainage at 3 months postoperatively.	From operation up to 3 months postoperatively
Secondary	Recurrence rate	To compare the difference in recurrence rate at 3 months postoperatively between the two groups;	From operation up to 3 months postoperatively
Secondary	Mortality rate	To compare the difference in mortality rate at 3 months postoperatively between the two groups;	From operation up to 3 months postoperatively
Secondary	Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation	Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.	At baseline and at 3 months after operation
Secondary	Quality of life assessment (EQ-5D-5L)	A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'postoperatively between the two groups.	At baseline and at 3 months after operation
Secondary	Change of Markwalder Grading Scale between groups from baseline to 3 months after operation	Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.	At baseline and at 3 months after operation
Secondary	Hospitalization costs	To compare the difference in hospitalization costs between the two groups.	At baseline.
Secondary	Length of hospitalization	To compare the difference in length of hospitalization between the two groups;	At baseline.