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

December 22, 2023 updated by: Weiming Liu, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Estimated)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Weiming Liu, MD
        • Sub-Investigator:
          • Liang Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rates
Time Frame: From operation up to 3 months postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: From operation up to 3 months postoperatively
To compare the difference in recurrence rate at 3 months postoperatively between the two groups;
From operation up to 3 months postoperatively
Mortality rate
Time Frame: From operation up to 3 months postoperatively
To compare the difference in mortality rate at 3 months postoperatively between the two groups;
From operation up to 3 months postoperatively
Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation
Time Frame: At baseline and at 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
Quality of life assessment (EQ-5D-5L)
Time Frame: At baseline and at 3 months after operation
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
Change of Markwalder Grading Scale between groups from baseline to 3 months after operation
Time Frame: At baseline and at 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
Hospitalization costs
Time Frame: At baseline.
To compare the difference in hospitalization costs between the two groups.
At baseline.
Length of hospitalization
Time Frame: At baseline.
To compare the difference in length of hospitalization between the two groups;
At baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Weiming Liu, M.D., Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 1, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX-B-2023035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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