Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

Study Overview
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Brief Summary
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A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.

Detailed Description
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Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimize the risk of symptomatic recurrences. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. The drainage is removed after 48 hours, which can be described as fixed-time drainage strategy. According to literature, the recurrence rate is 5-33% with this strategy. In the investigators' retrospective study, postoperative hematoma volume (p=0.001, B=0.028, Exp(B)=1.028, 95% CI 1.011-1.046) was found to significantly increase the risk of recurrence. Based on these results, an exhaustive drainage strategy may minimize postoperative hematoma volume and achieve a low recurrence rate and good outcomes. This is a prospective, multicenter, randomized controlled trial designed to include 304 participants over the age of 18 years presenting with a symptomatic CSDH verified on cranial computed tomography or magnetic resonance imaging. After informed consent is obtained, participants are randomly allocated to an exhaustive drainage or fixed-time drainage group. The primary endpoint is recurrence indicating a reoperation within 6 months. Secondary outcomes include modified Rankin Scale, Markwalder Grading Scale, European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L), rate of complications, rate of adverse events and effect on comorbidity.

Official Title
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A Randomized Controlled Trial of Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

Conditions
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Hematoma, Subdural, Chronic

Intervention / Treatment
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* Procedure: Operation
* Procedure: Fixed-time drainage
* Procedure: Exhaustive drainage
* Procedure: Postoperative computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of chronic subdural hematoma Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging Written informed consent from patients or their next of kin according to the patient's cognitive status Exclusion Criteria: No clinical symptoms correlating with chronic subdural hematoma 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 Severe coagulopathy or high risk of life-threatening bleeding 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed-time drainage<br>Drainage will be removed after 48 hours. | Procedure: Operation<br>* All participants are treated with burr-hole craniotomy and a drainage system as follows. Participants undergo surgical procedure under local anesthesia in the hemisphere with a lateral position, but general anesthesia is performed when participant cannot tolerate the operation. A single 1.5 cm burr hole is drilled over the maximum width of the hematoma cavity. After coagulating with bipolar diathermy, dura mater is opened with a cruciate incision. A soft catheter is placed carefully in all directions of the hematoma cavity for irrigating subdural collections with 1,000 mL warm Ringer's lactate saline until clarification. The drainage catheter is inserted ½ length of the maximum diameter of the hematoma cavity toward the frontal region. After the skin is closed, the catheter was connected to a soft collection bag that is placed under the head for passive drainage. During the drainage period, participants stay in bed until the drain is removed.<br>Procedure: Fixed-time drainage<br>* All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. The drainage will be removed after 48 hours.<br>Procedure: Postoperative computed tomography<br>* All participants undergo a CT scan before the drain is removed, and the last CT scan will be performed before the patient is discharged from the hospital.<br>|
| Experimental: Exhaustive drainage<br>Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter. | Procedure: Operation<br>* All participants are treated with burr-hole craniotomy and a drainage system as follows. Participants undergo surgical procedure under local anesthesia in the hemisphere with a lateral position, but general anesthesia is performed when participant cannot tolerate the operation. A single 1.5 cm burr hole is drilled over the maximum width of the hematoma cavity. After coagulating with bipolar diathermy, dura mater is opened with a cruciate incision. A soft catheter is placed carefully in all directions of the hematoma cavity for irrigating subdural collections with 1,000 mL warm Ringer's lactate saline until clarification. The drainage catheter is inserted ½ length of the maximum diameter of the hematoma cavity toward the frontal region. After the skin is closed, the catheter was connected to a soft collection bag that is placed under the head for passive drainage. During the drainage period, participants stay in bed until the drain is removed.<br>Procedure: Exhaustive drainage<br>* All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. If the computed tomography (CT) scan on the first day after surgery indicates that the affected brain region shows sufficient re-expansion, the drainage catheter will be removed when drainage ceases. If subdural collections remain in the hematoma cavity, the participant will be treated with 30,000 U urokinase injection into the hematoma cavity through the catheter. The catheter will be closed and reopened in 1.5-2 hours, and a CT scan will be performed when drainage ceases. If the CT scan shows sufficient re-expansion of the brain, the catheter will be removed. However, if the brain does not show good re-expansion and there is still a residual subdural collection, the above steps will be repeated. If the participant is subjected to urokinase injection for 3 times, the catheter will be removed when drainage ceases.<br>Procedure: Postoperative computed tomography<br>* All participants undergo a CT scan before the drain is removed, and the last CT scan will be performed before the patient is discharged from the hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-operations of chronic subdural hematoma | Rate of re-operations between fixed-time drainage group and exhaustive drainage group | From operation up to 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Modified Rankin Scale (MRS) between groups from baseline to 6 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 1, 3, and 6 months after operation | 
| Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 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 1, 3, and 6 months after operation | 
| Change of health related quality of life between groups from baseline to 6 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'. | At baseline, and at 1, 3, and 6 months after operation | 
| Rate of mortality between groups within 6 months | Rate of mortality between fixed-time drainage group and exhaustive drainage group | From operation up to 6 months postoperatively | 
| Rate of complications and adverse events between groups within 6 months | Rate of complications and adverse events between fixed-time drainage group and exhaustive drainage group within 6 months | From operation up to 6 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic subdural hematoma, fixed-time drainage, exhaustive drainage, drainage, craniostomy, urokinase