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

Hematoma, Subdural, Chronic Clinical Trial

— ECHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573387
• Other study ID #: KY 2020-094-02
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2020
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Beijing Tiantan Hospital
• Contact: Liang Wu, MD
• Phone: 15001333582
• Email: wuliang[@]bjtth.org
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: July 30, 2024
• Est. primary completion date: July 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Operation
All participants are treated with burr-hole craniotomy and a drainage system as follows. Participants undergo surgical procedure under local anesthesia in the hemisphere with a lateral position, but general anesthesia is performed when participant cannot tolerate the operation. A single 1.5 cm burr hole is drilled over the maximum width of the hematoma cavity. After coagulating with bipolar diathermy, dura mater is opened with a cruciate incision. A soft catheter is placed carefully in all directions of the hematoma cavity for irrigating subdural collections with 1,000 mL warm Ringer's lactate saline until clarification. The drainage catheter is inserted ½ length of the maximum diameter of the hematoma cavity toward the frontal region. After the skin is closed, the catheter was connected to a soft collection bag that is placed under the head for passive drainage. During the drainage period, participants stay in bed until the drain is removed.
• Fixed-time drainage
All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. The drainage will be removed after 48 hours.
• Exhaustive drainage
All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. If the computed tomography (CT) scan on the first day after surgery indicates that the affected brain region shows sufficient re-expansion, the drainage catheter will be removed when drainage ceases. If subdural collections remain in the hematoma cavity, the participant will be treated with 30,000 U urokinase injection into the hematoma cavity through the catheter. The catheter will be closed and reopened in 1.5-2 hours, and a CT scan will be performed when drainage ceases. If the CT scan shows sufficient re-expansion of the brain, the catheter will be removed. However, if the brain does not show good re-expansion and there is still a residual subdural collection, the above steps will be repeated. If the participant is subjected to urokinase injection for 3 times, the catheter will be removed when drainage ceases.
• Postoperative computed tomography
All participants undergo a CT scan before the drain is removed, and the last CT scan will be performed before the patient is discharged from the hospital.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Luhe 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 Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	Wangjing Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing
China	Wei County Hospital of Traditional Chinese Medicine	Handan	Hebei
China	Hengshui People's Hospital	Hengshui	Hebei
China	First People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	The Second Nanning People's Hospital	Nanning	Guangxi
China	Puning People's Hospital	Puning	Guangdong
China	First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	North China University of Science and Technology Affiliated Hospital	Tangshan	Hebei
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Yancheng Third People's Hospital	Yancheng	Jiangsu
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia
China	Xinxing County People's Hospital	Yunfu	Guangdong
China	Xiahuayuan District Hospital	Zhangjiakou	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wu L, Ou Y, Liu W. Letter to the Editor. Benefit of postoperative computed tomography in chronic subdural hematoma. J Neurosurg. 2019 Sep 13:1-3. doi: 10.3171/2019.5.JNS191212. Online ahead of print. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of re-operations of chronic subdural hematoma	Rate of re-operations between fixed-time drainage group and exhaustive drainage group	From operation up to 6 months postoperatively
Secondary	Change of Modified Rankin Scale (MRS) between groups from baseline to 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.	At baseline, and at 1, 3, and 6 months after operation
Secondary	Change of Markwalder Grading Scale (MGS) between groups from baseline to 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.	At baseline, and at 1, 3, and 6 months after operation
Secondary	Change of health related quality of life between groups from baseline to 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'.	At baseline, and at 1, 3, and 6 months after operation
Secondary	Rate of mortality between groups within 6 months	Rate of mortality between fixed-time drainage group and exhaustive drainage group	From operation up to 6 months postoperatively
Secondary	Rate of complications and adverse events between groups within 6 months	Rate of complications and adverse events between fixed-time drainage group and exhaustive drainage group within 6 months	From operation up to 6 months postoperatively