Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma
URANUS
1 other identifier
interventional
770
1 country
24
Brief Summary
Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Typical duration for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2025
CompletedFirst Posted
Study publicly available on registry
August 27, 2025
CompletedStudy Start
First participant enrolled
November 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 9, 2026
August 1, 2025
1.7 years
July 29, 2025
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence rate within 3 months after operation
To compare the difference in recurrence rate at 3 months postoperatively between the two groups.
From operation up to 3 months postoperatively
Secondary Outcomes (7)
Mortality rate within 3 months after operation
From operation up to 3 months postoperatively
Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation
"Day 0", "Day 2", "Month 1", "Month3" after operation
Change of Markwalder Grading Scale (MGS) between groups from baseline to 3 months after operation
"Day 0", "Day 2", "Month 1", "Month3" after operation
Change of Quality of life assessment (EQ-5D-5L) between groups from baseline to 3 months after operation
"Day 0", "Day 2", "Month 1", "Month3" after operation
Rate of complications and adverse events between groups within 3 months
From operation up to 3 months postoperatively
- +2 more secondary outcomes
Study Arms (2)
Neuroendoscope-assisted hematoma drainage
EXPERIMENTALUnder the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated.
Burr hole hematoma drainage
OTHERThe hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear.
Interventions
The procedure of endoscope-assisted hematoma drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as shown on CT scan. A bone flap measuring 2.0 cm × 2.0 cm is then created using a milling cutter. Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated. A subdural drainage tube is inserted, and postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.
The procedure of burr hole drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as indicated by CT scan. A subdural drainage tube is then inserted. The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear. Postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.
Eligibility Criteria
You may qualify if:
- Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
- CSDH 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.
You may not qualify if:
- No clinical symptoms correlating with chronic subdural hematoma.
- Lack of mass effect and midline shift \< 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons.
- Previous surgery for CSDH during the past 6 months.
- Previous intracranial surgery for any other neurological disorder.
- Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed.
- Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio \> 3.0; absolute platelet count \< 100×109/L).
- Postoperative compliance is suspected to be insufficient for 3-month follow-up visit.
- Reproductive-age women without verified negative pregnancy testing.
- Participating in another research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
Shantou central hosital
Shantou, Guangdong, 515031, China
People's Hospital of Longhua, Shenzhen
Shenzhen, Guangdong, 518109, China
Liuzhou worker's Hospital
Liuchow, Guangxi, 545007, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530006, China
Nanning First People's Hospital
Nanning, Guangxi, 530016, China
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Nanning, Guangxi, 530023, China
Wuzhou Gongren Hospital
Wuzhou, Guangxi, 543001, China
Hebei University of Engineering Affiliated Hospital
Handan, Hebei, 056002, China
Xingtai Central Hospital
Xingtai, Hebei, 054099, China
Changde First People's Hospital
Changde, Hunan, 415003, China
People's Hospital of Xiangxi Prefecture, Hunan Province
Jishou, Hunan, 416007, China
Yueyang Central Hospital
Yueyang, Hunan, 414020, China
Heji Hospital affiliated with Changzhi Medical College
Changzhi, Shanxi, 046011, China
Linfen People's Hospital
Linfen, Shanxi, 041000, China
Shanxi Provincial People's Hospital,Shanxi Medical University
Taiyuan, Shanxi, 030012, China
The Second Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710038, China
Mianyang 404 Hospital
Mianyang, Sichuan, 621000, China
the First People'S Hospital of Yibin
Yibin, Sichuan, 644606, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Pu'er People's Hospital
Pu'er, Yunnan, 665099, China
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Related Publications (26)
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PMID: 17986941BACKGROUNDAsghar M, Adhiyaman V, Greenway MW, Bhowmick BK, Bates A. Chronic subdural haematoma in the elderly--a North Wales experience. J R Soc Med. 2002 Jun;95(6):290-2. doi: 10.1258/jrsm.95.6.290.
PMID: 12042376BACKGROUNDBakheet MF, Pearce LA, Hart RG. Effect of addition of clopidogrel to aspirin on subdural hematoma: meta-analysis of randomized clinical trials. Int J Stroke. 2015 Jun;10(4):501-5. doi: 10.1111/ijs.12419. Epub 2014 Dec 3.
PMID: 25472690BACKGROUNDBanks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. doi: 10.1161/01.STR.0000258355.23810.c6. Epub 2007 Feb 1.
PMID: 17272767BACKGROUNDBrennan PM, Kolias AG, Joannides AJ, Shapey J, Marcus HJ, Gregson BA, Grover PJ, Hutchinson PJ, Coulter IC; British Neurosurgical Trainee Research Collaborative. The management and outcome for patients with chronic subdural hematoma: a prospective, multicenter, observational cohort study in the United Kingdom. J Neurosurg. 2017 Mar 17:1-8. doi: 10.3171/2016.8.JNS16134.test. Online ahead of print.
PMID: 28306417BACKGROUNDFrati A, Salvati M, Mainiero F, Ippoliti F, Rocchi G, Raco A, Caroli E, Cantore G, Delfini R. Inflammation markers and risk factors for recurrence in 35 patients with a posttraumatic chronic subdural hematoma: a prospective study. J Neurosurg. 2004 Jan;100(1):24-32. doi: 10.3171/jns.2004.100.1.0024.
PMID: 14743908BACKGROUNDJablawi F, Kweider H, Nikoubashman O, Clusmann H, Schubert GA. Twist Drill Procedure for Chronic Subdural Hematoma Evacuation: An Analysis of Predictors for Treatment Success. World Neurosurg. 2017 Apr;100:480-486. doi: 10.1016/j.wneu.2017.01.037. Epub 2017 Jan 19.
PMID: 28109862BACKGROUNDKudo H, Kuwamura K, Izawa I, Sawa H, Tamaki N. Chronic subdural hematoma in elderly people: present status on Awaji Island and epidemiological prospect. Neurol Med Chir (Tokyo). 1992 Apr;32(4):207-9. doi: 10.2176/nmc.32.207.
PMID: 1378564BACKGROUNDKurabe S, Ozawa T, Watanabe T, Aiba T. Efficacy and safety of postoperative early mobilization for chronic subdural hematoma in elderly patients. Acta Neurochir (Wien). 2010 Jul;152(7):1171-4. doi: 10.1007/s00701-010-0627-4. Epub 2010 Mar 25.
PMID: 20336332BACKGROUNDLeroy HA, Aboukais R, Reyns N, Bourgeois P, Labreuche J, Duhamel A, Lejeune JP. Predictors of functional outcomes and recurrence of chronic subdural hematomas. J Clin Neurosci. 2015 Dec;22(12):1895-900. doi: 10.1016/j.jocn.2015.03.064. Epub 2015 Aug 8.
PMID: 26260114BACKGROUNDLiu 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.
PMID: 24995782BACKGROUNDLu J, Shen D, Hu F, Zhou J, Lan F, Guo D, Liu T. An improved electronic twist-drill craniostomy procedure with post-operative urokinase instillation in treating chronic subdural hematoma. Clin Neurol Neurosurg. 2015 Sep;136:61-5. doi: 10.1016/j.clineuro.2015.05.037. Epub 2015 Jun 3.
PMID: 26067723BACKGROUNDMiles LA, Greengard JS, Griffin JH. A comparison of the abilities of plasma kallikrein, beta-Factor XIIa, Factor XIa and urokinase to activate plasminogen. Thromb Res. 1983 Feb 15;29(4):407-17. doi: 10.1016/0049-3848(83)90244-x.
PMID: 6344314BACKGROUNDMori K, Maeda M. Surgical treatment of chronic subdural hematoma in 500 consecutive cases: clinical characteristics, surgical outcome, complications, and recurrence rate. Neurol Med Chir (Tokyo). 2001 Aug;41(8):371-81. doi: 10.2176/nmc.41.371.
PMID: 11561347BACKGROUNDNakaguchi H, Tanishima T, Yoshimasu N. Factors in the natural history of chronic subdural hematomas that influence their postoperative recurrence. J Neurosurg. 2001 Aug;95(2):256-62. doi: 10.3171/jns.2001.95.2.0256.
PMID: 11780895BACKGROUNDNeils DM, Singanallur PS, Wang H, Tracy P, Klopfenstein J, Dinh D, Elwood PW, Fassett D, McCall T, Lin J, Tsung A. Recurrence-free chronic subdural hematomas: a retrospective analysis of the instillation of tissue plasminogen activator in addition to twist drill or burr hole drainage in the treatment of chronic subdural hematomas. World Neurosurg. 2012 Jul;78(1-2):145-9. doi: 10.1016/j.wneu.2011.08.032. Epub 2011 Nov 7.
PMID: 22120294BACKGROUNDQiu S, Zhuo W, Sun C, Su Z, Yan A, Shen L. Effects of atorvastatin on chronic subdural hematoma: A systematic review. Medicine (Baltimore). 2017 Jun;96(26):e7290. doi: 10.1097/MD.0000000000007290.
PMID: 28658127BACKGROUNDRobinson RG. Chronic subdural hematoma: surgical management in 133 patients. J Neurosurg. 1984 Aug;61(2):263-8. doi: 10.3171/jns.1984.61.2.0263.
PMID: 6737050BACKGROUNDSantarius T, Hutchinson PJ. Chronic subdural haematoma: time to rationalize treatment? Br J Neurosurg. 2004 Aug;18(4):328-32. doi: 10.1080/02688690400004845.
PMID: 15702829BACKGROUNDSantarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
PMID: 19782872BACKGROUNDShapey J, Glancz LJ, Brennan PM. Chronic Subdural Haematoma in the Elderly: Is It Time for a New Paradigm in Management? Curr Geriatr Rep. 2016;5:71-77. doi: 10.1007/s13670-016-0166-9. Epub 2016 Mar 23.
PMID: 27213133BACKGROUNDStanisic M, Pripp AH. A Reliable Grading System for Prediction of Chronic Subdural Hematoma Recurrence Requiring Reoperation After Initial Burr-Hole Surgery. Neurosurgery. 2017 Nov 1;81(5):752-760. doi: 10.1093/neuros/nyx090.
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PMID: 12810784BACKGROUNDYu GJ, Han CZ, Zhang M, Zhuang HT, Jiang YG. Prolonged drainage reduces the recurrence of chronic subdural hematoma. Br J Neurosurg. 2009 Dec;23(6):606-11. doi: 10.3109/02688690903386983.
PMID: 19922274BACKGROUNDZhang Y, Chen S, Xiao Y, Tang W. Effects of Dexamethasone in the Treatment of Recurrent Chronic Subdural Hematoma. World Neurosurg. 2017 Sep;105:115-121. doi: 10.1016/j.wneu.2017.05.135. Epub 2017 May 31.
PMID: 28578110BACKGROUNDWu L, Yan Y, Deng Y, Li Y, Liu W, Gao G; URANUS Trial Collaborators. Neuroendoscopy-assisted drainage versus burr hole drainage for chronic subdural hematoma (URANUS): study protocol for a multicenter randomized controlled trial. Trials. 2026 Mar 17. doi: 10.1186/s13063-026-09629-z. Online ahead of print.
PMID: 41845395DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoyi Gao, MD
Beijing Tiantan Hospital
- STUDY DIRECTOR
Liang Wu, MD
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The design is open labeled with only the investigators for postoperative follow-up evaluation, the outcome assessors, and data analysts being blinded in all 24 centers. Before outcome assessment begins at every follow-up evaluation, the patients will be reminded not to reveal any information about their group allocation. If details of group allocation can be detected by the investigator during follow-ups, another blinded researcher will replace to evaluate outcome.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2025
First Posted
August 27, 2025
Study Start
November 19, 2025
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 9, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing will be opened 6 months after the completion of the study, with a duration of 5 years.
- Access Criteria
- Access to IPD is available to collaborators within the original research consortium. External researchers may apply via a formal request to the principal investigator (PI), including a rationale for access, proposed analysis plan, and confirmation of compliance with institutional review board (IRB) requirements. All users must sign a data usage agreement prior to receiving data.
This study plans to share de-identified individual participant data (IPD) six months after the publication of its core findings, aiming to enhance transparency and foster scientific collaboration in the field. The shared data will encompass: ① clinical indicators at baseline and follow-up (e.g., demographic characteristics, laboratory tests, outcome events); ② records of experimental interventions (grouping, surgical protocols); and ③ exclusion of identifiable information (names, precise birth dates, addresses, etc.). The data will be stored in an encrypted institutional data repository (or a public repository such as Figshare), and access will be granted only after the signing of a Data Use Agreement (DUA).