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

Capital Medical University

Status: Completed

Conditions: Hematoma, Subdural, Chronic

Treatments: Procedure: Fixed-time drainage; Procedure: Postoperative computed tomography; Procedure: Exhaustive drainage; Procedure: Operation

Study type: Interventional

Funder types: Other

Identifiers

NCT04573387

KY 2020-094-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 309 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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309 participants in 2 patient groups

Fixed-time drainage

Active Comparator group

Description:

Drainage will be removed after 48 hours.

Treatment:

Procedure: Operation

Procedure: Postoperative computed tomography

Procedure: Fixed-time drainage

Exhaustive drainage

Experimental group

Description:

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

Treatment:

Procedure: Operation

Procedure: Exhaustive drainage

Procedure: Postoperative computed tomography