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Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma

2026年7月25日 更新者：Jie Shen、The Second Hospital of Anhui Medical University

Frontal Versus Parietal Eminence Twist-Drill Drainage for Chronic Subdural Hematoma

This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH).

The target population is adults with a unilateral chronic subdural hematoma who need surgical drainage based on their symptoms and imaging findings (CT/MRI).

The main questions this study is designed to answer are:

  • Does the puncture site affect the risk of same-side cSDH recurrence requiring reoperation within 3 months
  • Does the puncture site affect recovery and key clinical outcomes after surgery (including functional status and postoperative recovery measures)

There are two groups, researchers will compare:

  • Group A: patients receiving puncture at the frontal region vs.
  • Group B: patients receiving puncture near the parietal eminence to determine whether one puncture site leads to better outcomes than the other.

Participants will:

  • undergo a surgical procedure where, based on random assignment, the puncture site is either frontal or near the parietal eminence;
  • receive closed-system drainage after a twist-drill puncture;
  • complete follow-up assessments at discharge, 30 days, 3 months after surgery, which will include symptom review and imaging (CT) evaluations to check hematoma changes and recurrence;
  • have safety monitoring throughout the study period to record any complications or adverse events.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a (multi-center) prospective, randomized, parallel-group, assessor-blinded clinical trial in eligible patients with unilateral chronic subdural hematoma (cSDH) to compare the effects of puncture-site location on outcomes after minimally invasive drainage: participants will be randomly assigned 1:1 to Group A (frontal twist-drill puncture drainage) or Group B (parietal eminence twist-drill puncture drainage), with both groups receiving standardized closed-system subdural drainage and postoperative management; random allocation will be concealed using a secure electronic randomization system or sealed opaque envelopes prepared by a researcher not involved in surgery or outcome assessment. The primary outcome is the rate of ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery (recurrence defined as symptomatic re-accumulation or enlargement confirmed by imaging and judged by the treating team to require repeat intervention). Secondary outcomes include postoperative residual hematoma maximum thickness and volume at 24-48 hours, pneumocephalus volume at 24-48 hours, reduction in midline shift, brain re-expansion rate, drainage duration, length of hospital stay, postoperative complications, Markwalder grading and modified Rankin Scale (mRS) scores at 30 days/3 months, and mortality at 30 days and 3 months; although surgeon blinding is not feasible, radiological and clinical outcome assessors and statisticians will be blinded whenever possible, with anonymized postoperative CT images assessed independently by trained reviewers.

研究类型

介入性

注册 (估计的)

440

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Anhui
      • Hefei、Anhui、中国、230601
        • The Second Affiliated Hospital of Anhui Medical University
        • 接触：
          • Jie Shen, MD
          • 电话号码：+8613515515154
    • Jiangsu
      • Huai'an、Jiangsu、中国、223300
        • Huai'an first people's hospital
        • 接触：
      • Yangzhou、Jiangsu、中国、225009
        • Yangzhou University Affiliated Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.
  3. Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.

  4. Radiological indication for surgery, defined as one of the following:

    Maximum hematoma thickness ≥ 10 mm, and/or Midline shift ≥ 5 mm, or Even if these thresholds are not met, clinically significant symptoms requiring surgery as judged by the treating neurosurgeon.

  5. Plan to undergo twist-drill puncture drainage with a closed drainage system.
  6. Written informed consent signed by the participant or their legally authorized representative.

Exclusion Criteria:

  1. Bilateral cSDH requiring simultaneous bilateral surgery.
  2. Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component.
  3. Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively.
  4. Previous surgery on the ipsilateral side for cSDH.
  5. Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm.
  6. Severe coagulation disorder that cannot be corrected before surgery.
  7. Life expectancy < 6 months.
  8. Pregnancy.
  9. Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage)
The puncture point is selected within the anterior coverage region of the hematoma area-typically within the frontal bone region anterior to the coronal suture-avoiding the frontal sinus, obvious cortical veins, and key functional areas. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment.
程序：Frontal-region puncture drainage
Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
有源比较器：Parietal Eminence Burr Hole Puncture Group(twist-drill drainage)
The puncture point is selected at the vertex (crown vertex) region within the hematoma area. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment.
程序：Parietal Eminence region puncture drainage
Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
大体时间：3 months
Recurrence defined as ipsilateral hematoma re-enlargement or symptom recurrence, confirmed by imaging, and judged by the treatment team to require repeat surgical intervention.
3 months

次要结果测量

结果测量
措施说明
大体时间
Residual hematoma maximum thickness
大体时间："Day 2", "Month 1", "Month3" after operation
Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH.
"Day 2", "Month 1", "Month3" after operation
Residual hematoma volume
大体时间："Day 2", "Month 1", "Month3" after operation
Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH.
"Day 2", "Month 1", "Month3" after operation
Intra-cranial pneumocephalus volume
大体时间："Day 2", "Month 1" after operation
Measured on postoperative CT as the volume of intracranial pneumocephalus (air within the cranial cavity).
"Day 2", "Month 1" after operation
Improvement in midline shift
大体时间："Day 2", "Month 1", "Month3" after operation
Assessed on follow-up imaging by comparing the midline shift against baseline/protocol-defined preoperative value; reported as the degree of improvement.
"Day 2", "Month 1", "Month3" after operation
Drain duration / catheter indwelling time
大体时间：immediately after the procedure
Time from catheter placement to catheter removal, reported as hours/days per protocol.
immediately after the procedure
Postoperative complications
大体时间：From operation up to 3 months postoperatively

Any adverse events occurring postoperatively, including (but not limited to):

acute subdural hematoma, intracerebral hemorrhage, seizure, infection, tension pneumocephalus, and drain/catheter misplacement.
From operation up to 3 months postoperatively
Markwalder grade at 7days, 30 days and 3 months
大体时间："Day 7", "Month 1", "Month3" after operation
Neurological symptom severity scored using the Markwalder scale at the specified follow-up time points.
"Day 7", "Month 1", "Month3" after operation
Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months
大体时间："Day 7", "Month 1", "Month3" after operation
Functional status measured by mRS at the specified follow-up time points.
"Day 7", "Month 1", "Month3" after operation
Mortality rate within 3 months after operation
大体时间：From operation up to 3 months postoperatively
Death from any cause assessed at 3 months after surgery.
From operation up to 3 months postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Second Hospital of Anhui Medical University

合作者

Yangzhou University
Huai'an First People's Hospital

调查人员

  • 研究主任：qi li, MD、The Second Hospital of Anhui Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年7月22日

首先提交符合 QC 标准的

2026年7月25日

首次发布 (实际的)

2026年7月28日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月25日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SAHAMU-CSDH-RCT-002
  • 202512022 (其他赠款/资助编号：Anhui Provincial International Joint Research Center for Advanced Technology in Medical Imaging, Anhui University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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