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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    304
  • sponsor
    Beijing Tiantan Hospital
Updated on 3 February 2021

Summary

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.

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.

Details
Condition Chronic subdural hematoma
Treatment operation, Fixed-time drainage, Exhaustive drainage, Postoperative computed tomography
Clinical Study IdentifierNCT04573387
SponsorBeijing Tiantan Hospital
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

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
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