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Chronic Subdural HematomaURANUSNCT07144423

Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma

A study testing Endoscope-assisted hematoma drainage and Burr hole hematoma drainage in people with Chronic Subdural Hematoma, run by Beijing Tiantan Hospital at 24 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Chronic Subdural Hematoma
What is being tested?
Endoscope-assisted hematoma drainage and Burr hole hematoma drainage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
24 sitesChina
Study dates
19 Nov 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liang Wu, MD contact

18301674233

jasewl@sina.com

Yu Yan, MB contact

13701141637

2710575494@qq.com

24 sites in 1 country

China24 sites, 24 recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

    Guoyi Gao, MD, 13801874393 ext. +86, gao3@sina.com

    Guoyi Gao, MD

    Recruiting

  • Changde First People's Hospital

    Changde, Hunan, 415003

    Jiangli Wen, M.D., 18397356106

    Recruiting

  • Heji Hospital affiliated with Changzhi Medical College

    Changzhi, Shanxi, 046011

    Tiezhu Guo, M.D., 15635559010

    Recruiting

  • Hebei University of Engineering Affiliated Hospital

    Handan, Hebei, 056002

    Xiushan Li, M.D., 13592602885

    Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030

    Jiyong Gu, M.D., 18029602088

    Recruiting

  • People's Hospital of Xiangxi Prefecture, Hunan Province

    Jishou, Hunan, 416007

    Changhua Xiang, M.D., 13762109008

    Recruiting

  • Linfen People's Hospital

    Linfen, Shanxi, 041000

    Honggang Ren, M.D., 18835791653

    Recruiting

  • Liuzhou worker's Hospital

    Liuzhou, Guangxi, 545007

    Quan Liu, M.D., 15577718510

    Recruiting

  • Mianyang 404 Hospital

    Mianyang, Sichuan, 621000

    Zhiyong Gou, M.D., 18909010077

    Recruiting

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530006

    Chunhai Tang, M.D., 15077195824

    Recruiting

  • Nanning First People's Hospital

    Nanning, Guangxi, 530016

    Feng Wei, M.D., 15978192443

    Recruiting

  • The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

    Nanning, Guangxi, 530023

    Yi Huang, M.D., 18677140190

    Recruiting

  • Pu'er People's Hospital

    Pu'er, Yunnan, 665099

    Xingchang Li, M.D., 18087915959

    Recruiting

  • Shantou central hosital

    Shantou, Guangdong, 515031

    Ke Xu, M.D., 15915553501

    Recruiting

  • People's Hospital of Longhua, Shenzhen

    Shenzhen, Guangdong, 518109

    Zheng Liu, M.D., 15889644064

    Recruiting

  • Shanxi Provincial People's Hospital,Shanxi Medical University

    Taiyuan, Shanxi, 030012

    Xiaohui Yao, M.D., 13803439803

    Recruiting

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Yongxin Wang, M.D., 18699147876

    Recruiting

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Zhipeng Su, M.D., 18324239321

    Recruiting

  • Wuzhou Gongren Hospital

    Wuzhou, Guangxi, 543001

    Zhongyong Deng, M.D., 13878401206

    Recruiting

  • The Second Affiliated Hospital of Xi'an Medical University

    Xi’an, Shanxi, 710038

    Haikang Zhao, M.D., 18302996683

    Recruiting

  • First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Zhanxiang Wang, M.D., 13666082686

    Recruiting

  • Xingtai Central Hospital

    Xingtai, Hebei, 054099

    Jinmin Hao, M.D., 13932995289

    Recruiting

  • the First People'S Hospital of Yibin

    Yibin, Sichuan, 644606

    Hua Peng, M.D., 15183906301

    Recruiting

  • Yueyang Central Hospital

    Yueyang, Hunan, 414020

    Jian Zhou, M.D., 15071057913

    Recruiting

Other trials in China

About this study

Official title: Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma: A Multicenter Randomized Controlled Trial, URANUS

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.

Read the detailed description

Chronic subdural hematoma (CSDH) is a common disease in neurosurgery. It is generally considered to be a closed fluid collection situated between the dura mater and arachnoid mater, formed by blood or blood degradation products. This collection causes a local mass effect, compressing adjacent brain tissue and leading to varying degrees of neurological dysfunction. In severe cases, it can induce brain herniation, endangering the patient's life. In recent years, despite the availability of various pharmacological and surgical treatment options for CSDH, the efficacy and long-term prognosis of these treatment methods and strategies remain not entirely clear, and a standardized treatment approach has yet to be established. Neuroendoscopy-assisted hematoma drainage is one of the treatment methods for CSDH, but its current application is not widespread. The core of this method involves neurosurgeons directly observing the hematoma structure during surgery with the assistance of a neuroendoscope, enabling them to thoroughly irrigate and aspirate the hematoma under direct vision and sever hematoma septations. This approach enhances the hematoma clearance rate, ultimately reducing the amount of postoperative hematoma residue. Compared with conventional burr-hole drainage, neuroendoscopy-assisted burr-hole drainage reduces the recurrence rate of CSDH and shortens the duration of postoperative drainage. This study aims to conduct a multicenter randomized controlled trial comparing neuroendoscopy-assisted hematoma drainage with burr-hole drainage, with the objective of scientifically and rigorously determining the optimal clinical treatment strategy for CSDH.

Being tested
Endoscope-assisted hematoma drainage, Burr hole hematoma drainage
Keywords
Chronic Subdural Hematoma, Neuroendoscopy-assisted Drainage, Burr Hole Drainage, Recurrence Rate, Neurological Outcome
Medical subject headings
Hematoma, Subdural, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscope-assisted hematoma drainageProcedure or surgery

    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.

  • Burr hole hematoma drainageProcedure or surgery

    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.

Study groups in NCT07144423
Study groupRoleWhat they receive
Neuroendoscope-assisted hematoma drainageExperimentalUnder the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated.
Receives: Procedure: Endoscope-assisted hematoma drainage
Burr hole hematoma drainageOtherThe hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear.
Receives: Procedure: Burr hole hematoma drainage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence rate within 3 months after operation

    To compare the difference in recurrence rate at 3 months postoperatively between the two groups.

    Measured: From operation up to 3 months postoperatively

Secondary outcomes (7)

  1. Mortality rate within 3 months after operation

    To compare the difference in mortality rate at 3 months postoperatively between the two groups.

    Measured: From operation up to 3 months postoperatively

  2. Change of Modified Rankin Scale (MRS) between groups from baseline to 3 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.

    Measured: "Day 0", "Day 2", "Month 1", "Month3" after operation

  3. Change of Markwalder Grading Scale (MGS) between groups from baseline to 3 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.

    Measured: "Day 0", "Day 2", "Month 1", "Month3" after operation

  4. Change of Quality of life assessment (EQ-5D-5L) between groups from baseline to 3 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'postoperatively between the two groups.

    Measured: "Day 0", "Day 2", "Month 1", "Month3" after operation

  5. Rate of complications and adverse events between groups within 3 months

    Rate of complications and adverse events between the two groups within 3 months.

    Measured: From operation up to 3 months postoperatively

  6. Postoperative drainage time

    To compare the difference in length of postoperative drainage between the two groups.

    Measured: immediately after the procedure

  7. Length of hospitalization

    To compare the difference in length of hospitalization between the two groups.

    Measured: immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start19 Nov 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
770 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07144423
Sponsor's protocol ID
HX-A-2025027
Acronym
URANUS
Status last verified
Aug 2025
First submitted
29 Jul 2025
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Abouzari M, Rashidi A, Rezaii J, Esfandiari K, Asadollahi M, Aleali H, Abdollahzadeh M. The role of postoperative patient posture in the recurrence of traumatic chronic subdural hematoma after burr-hole surgery. Neurosurgery. 2007 Oct;61(4):794-7; discussion 797. doi: 10.1227/01.NEU.0000298908.94129.67.

    PubMed 17986941

  • Asghar 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.

    PubMed 12042376

  • Bakheet 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.

    PubMed 25472690

  • Banks 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.

    PubMed 17272767

  • Brennan 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.

    PubMed 28306417

  • Frati 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.

    PubMed 14743908

  • Jablawi 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.

    PubMed 28109862

  • Kudo 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.

    PubMed 1378564

  • Kurabe 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.

    PubMed 20336332

  • Leroy 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.

    PubMed 26260114

  • 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.

    PubMed 24995782

  • Lu 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.

    PubMed 26067723

  • Miles 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.

    PubMed 6344314

  • Mori 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.

    PubMed 11561347

  • Nakaguchi 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.

    PubMed 11780895

Questions about this trial

What is this clinical trial studying?

A study testing Endoscope-assisted hematoma drainage and Burr hole hematoma drainage in people with Chronic Subdural Hematoma, run by Beijing Tiantan Hospital at 24 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liang Wu, MD (18301674233, jasewl@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate within 3 months after operation (time frame: From operation up to 3 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07144423, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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