An interventional study of Frontal-region puncture drainage and Parietal Eminence region puncture drainage in Chronic Subdural Hematoma, sponsored by The Second Hospital of Anhui Medical University. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by The Second Hospital of Anhui Medical University · Not applicable, Interventional, and Treatment
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:
There are two groups, researchers will compare:
Participants will:
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 440 is above the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →The Second Hospital of Anhui Medical University is the lead sponsor of 30 studies on the registry; 18 are open to participants now.
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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, symptoms requiring surgery as judged by the treating neurosurgeon.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Frontal-region puncture 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.
Procedure: Parietal Eminence region puncture drainage
Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
Recurrence defined as ipsilateral hematoma re-enlargement or symptom recurrence, confirmed by imaging, and judged by the treatment team to require repeat surgical intervention.
Time frame: 3 months
Residual hematoma maximum thickness
Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH.
Time frame: "Day 2", "Month 1", "Month3" after operation
Residual hematoma volume
Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH.
Time frame: "Day 2", "Month 1", "Month3" after operation
Intra-cranial pneumocephalus volume
Measured on postoperative CT as the volume of intracranial pneumocephalus (air within the cranial cavity).
Time frame: "Day 2", "Month 1" after operation
Improvement in midline shift
Assessed on follow-up imaging by comparing the midline shift against baseline/protocol-defined preoperative value; reported as the degree of improvement.
Time frame: "Day 2", "Month 1", "Month3" after operation
Drain duration / catheter indwelling time
Time from catheter placement to catheter removal, reported as hours/days per protocol.
Time frame: immediately after the procedure
Postoperative complications
Any adverse events occurring postoperatively, including (but not limited to): acute subdural hematoma, intracerebral hemorrhage, seizure, infection, tension pneumocephalus, and drain/catheter misplacement.
Time frame: From operation up to 3 months postoperatively
Markwalder grade at 7days, 30 days and 3 months
Neurological symptom severity scored using the Markwalder scale at the specified follow-up time points.
Time frame: "Day 7", "Month 1", "Month3" after operation
Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months
Functional status measured by mRS at the specified follow-up time points.
Time frame: "Day 7", "Month 1", "Month3" after operation
Mortality rate within 3 months after operation
Death from any cause assessed at 3 months after surgery.
Time frame: From operation up to 3 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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The Second Hospital of Anhui Medical University