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

Hematoma, Subdural, Chronic Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic

• NCT number: NCT04573387
• Study type: Interventional
• Source: Beijing Tiantan Hospital
• Contact: Liang Wu, MD
• Phone: 15001333582
• Email: wuliang@bjtth.org
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2020
• Completion date: July 30, 2024