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

NCT06072053 | Unknown DMC

• 1 other identifier: HX-B-2023035
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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 strategy for patients with Chronic Subdural Hematoma.

Conditions

Chronic Subdural Hematoma

Keywords

Chronic Subdural Hematoma; YL-1 Needle Drainage; Burr Hole Craniostomy; Exhaustive drainage strategy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Recurrence rate

  From operation up to 3 months postoperatively

• Mortality rate

  From operation up to 3 months postoperatively

• Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation

  At baseline and at 3 months after operation

• Quality of life assessment (EQ-5D-5L)

  At baseline and at 3 months after operation

• Change of Markwalder Grading Scale between groups from baseline to 3 months after operation

  At baseline and at 3 months after operation

Study Arms (2)

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.

Procedure: Burr Hole Craniostomy and Postoperative Exhaustive Drainage Strategy

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.

Procedure: YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy

Interventions

Burr Hole Craniostomy and Postoperative Exhaustive Drainage Strategy PROCEDURE

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.

BHC group

YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy PROCEDURE

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.

YL-1 Needle Puncture group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CSDH recruited from the neurosurgery departments of 12 medical centers in China who had significant clinical symptoms confirmed by computed tomography or magnetic resonance imaging. Six medical centers each used BHC as well as YL-1 puncture needles for comparison.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related 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.

  PMID: 24096761 BACKGROUND

• 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.

  PMID: 28306417 BACKGROUND

• 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.

  PMID: 35593710 BACKGROUND

• 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.

  PMID: 25224156 BACKGROUND

• 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.

  PMID: 27857917 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Weiming Liu, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Liu, M.D.

CONTACT

13701182770; liuweimingnsok@sina.com

Liang Wu, M.D.

CONTACT

15001333582; jasewl@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 10, 2023
• Study Start: December 22, 2023
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)