Clinical trial NCT04573387: Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy
Official title: A Randomized Controlled Trial of Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematoma, Subdural, Chronic
Keywords: chronic subdural hematoma
fixed-time drainage
exhaustive drainage
drainage
craniostomy
urokinase
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of re-operations of chronic subdural hematoma
timeFrame: From operation up to 6 months postoperatively
Secondary outcomes:
measure: Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation
timeFrame: At baseline, and at 1, 3, and 6 months after operation
measure: Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 months after operation
timeFrame: At baseline, and at 1, 3, and 6 months after operation
measure: Change of health related quality of life between groups from baseline to 6 months after operation
timeFrame: At baseline, and at 1, 3, and 6 months after operation
measure: Rate of mortality between groups within 6 months
timeFrame: From operation up to 6 months postoperatively
measure: Rate of complications and adverse events between groups within 6 months
timeFrame: From operation up to 6 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Wangjing Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Puning
country: China
facility: Puning People's Hospital
state: Guangdong
city: Handan
country: China
facility: Wei County Hospital of Traditional Chinese Medicine
state: Hebei
city: Hengshui
country: China
facility: Hengshui People's Hospital
state: Hebei
city: Qinhuangdao
country: China
facility: First Hospital of Qinhuangdao
state: Hebei
city: Tangshan
country: China
facility: North China University of Science and Technology Affiliated Hospital
state: Hebei
city: Zhangjiakou
country: China
facility: Xiahuayuan District Hospital
state: Hebei
city: Lianyungang
country: China
facility: First People's Hospital of Lianyungang
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng Third People's Hospital
state: Jiangsu
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
affiliation: Beijing Tiantan Hospital
name: Weiming Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ou Y, Yu X, Liu X, Jing Q, Liu B, Liu W. A Comparative Study of Chronic Subdural Hematoma in Patients With and Without Head Trauma: A Retrospective Cross Sectional Study. Front Neurol. 2020 Nov 27;11:588242. doi: 10.3389/fneur.2020.588242. eCollection 2020.
citation: Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. An Exhaustive Drainage Strategy in Burr-hole Craniostomy for Chronic Subdural Hematoma. World Neurosurg. 2019 Jun;126:e1412-e1420. doi: 10.1016/j.wneu.2019.03.111. Epub 2019 Mar 19.
citation: Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. The Clinical Characteristics, Treatment, and Outcomes of Chronic Subdural Hematoma in Young Patients. World Neurosurg. 2019 May;125:e1241-e1246. doi: 10.1016/j.wneu.2019.02.017. Epub 2019 Feb 22.
citation: Ou Y, Dong J, Wu L, Xu L, Wang L, Liu B, Li J, Liu W. A comparative study of chronic subdural hematoma in three age ranges: Below 40 years, 41-79 years, and 80 years and older. Clin Neurol Neurosurg. 2019 Mar;178:63-69. doi: 10.1016/j.clineuro.2019.01.018. Epub 2019 Jan 29.
citation: Liu W, Bakker NA, Groen RJ. Chronic subdural hematoma: a systematic review and meta-analysis of surgical procedures. J Neurosurg. 2014 Sep;121(3):665-73. doi: 10.3171/2014.5.JNS132715. Epub 2014 Jul 4.
citation: Wu L, Ou Y, Liu W. Letter to the Editor. Benefit of postoperative computed tomography in chronic subdural hematoma. J Neurosurg. 2019 Sep 13;131(6):1992-1993. doi: 10.3171/2019.5.JNS191212. Print 2019 Dec 1. No abstract available.