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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-29

Study Completion Date

2024-12-15

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.

Conditions

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Hematoma, Subdural, Chronic

Keywords

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chronic subdural hematoma fixed-time drainage exhaustive drainage drainage craniostomy urokinase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The design is open labeled with only the investigators for postoperative follow-up evaluation, the outcome assessors, and data analysts being blinded in all 19 centers. Before outcome assessment begins at every follow-up evaluation, the patients will be reminded not to reveal any information about their group allocation. If details of group allocation can be detected by the investigator during follow-ups, another blinded researcher will replace to evaluate outcome.

Study Groups

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Fixed-time drainage

Drainage will be removed after 48 hours.

Group Type ACTIVE_COMPARATOR

Operation

Intervention Type PROCEDURE

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.

Fixed-time drainage

Intervention Type PROCEDURE

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.

Postoperative computed tomography

Intervention Type PROCEDURE

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.

Exhaustive drainage

Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter.

Group Type EXPERIMENTAL

Operation

Intervention Type PROCEDURE

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.

Exhaustive drainage

Intervention Type PROCEDURE

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.

Postoperative computed tomography

Intervention Type PROCEDURE

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.

Interventions

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Operation

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.

Intervention Type PROCEDURE

Fixed-time drainage

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.

Intervention Type PROCEDURE

Exhaustive drainage

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.

Intervention Type PROCEDURE

Postoperative computed tomography

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Weiming Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiming Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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