Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy
- Conditions
- Hematoma, Subdural, Chronic
- Interventions
- Procedure: OperationProcedure: Exhaustive drainageProcedure: Fixed-time drainageProcedure: Postoperative computed tomography
- Registration Number
- NCT04573387
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 309
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fixed-time drainage Postoperative computed tomography Drainage will be removed after 48 hours. Exhaustive drainage Exhaustive drainage Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter. Exhaustive drainage Postoperative computed tomography Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter. Fixed-time drainage Operation Drainage will be removed after 48 hours. Exhaustive drainage Operation Drainage will be removed when postoperative hematoma volume is minimized with repeated urokinase injection into hematoma cavity through catheter. Fixed-time drainage Fixed-time drainage Drainage will be removed after 48 hours.
- Primary Outcome Measures
Name Time Method Rate of re-operations of chronic subdural hematoma From operation up to 6 months postoperatively Rate of re-operations between fixed-time drainage group and exhaustive drainage group
- Secondary Outcome Measures
Name Time Method Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation At baseline, and at 1, 3, and 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.
Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 months after operation At baseline, and at 1, 3, and 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.
Change of health related quality of life between groups from baseline to 6 months after operation At baseline, and at 1, 3, and 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'.
Rate of complications and adverse events between groups within 6 months From operation up to 6 months postoperatively Rate of complications and adverse events between fixed-time drainage group and exhaustive drainage group within 6 months
Rate of mortality between groups within 6 months From operation up to 6 months postoperatively Rate of mortality between fixed-time drainage group and exhaustive drainage group
Trial Locations
- Locations (17)
Beijing Ditan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Wangjing Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
Puning People's Hospital
🇨🇳Puning, Guangdong, China
Wei County Hospital of Traditional Chinese Medicine
🇨🇳Handan, Hebei, China
Hengshui People's Hospital
🇨🇳Hengshui, Hebei, China
First Hospital of Qinhuangdao
🇨🇳Qinhuangdao, Hebei, China
North China University of Science and Technology Affiliated Hospital
🇨🇳Tangshan, Hebei, China
Xiahuayuan District Hospital
🇨🇳Zhangjiakou, Hebei, China
First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Yancheng Third People's Hospital
🇨🇳Yancheng, Jiangsu, China
People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia, China
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China