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Intracerebral HaemorrhageNESICH 2NCT06894433

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

A study testing neuroendoscopic surgery and craniotomy in people with Intracerebral Haemorrhage, run by Southwest Hospital, China at 2 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
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Trial summary

This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intracerebral Haemorrhage
What is being tested?
neuroendoscopic surgery and craniotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
2 sitesChina
Study dates
1 Jun 2025to 31 Dec 2028
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years old, male or female;
  • The time between onset and admission to the first diagnostic CT is within 24 hours (for no bystanders and the time of onset is unknown, the time of the last known patient in good condition is used);
  • Patients with supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage) whose hematoma volume is ≥50ml or whose hematoma produces obvious space occupying effect and requires emergency surgery (including patients with cerebral hernia signs such as retarding or dilatation of light reflex of one pupil);
  • Before randomization, GCS score was 5-14, NIHSS score was ≥6;
  • mRS Before onset: 0-1 score;
  • Randomization within 24 hours after the first diagnostic CT;
  • The patient or family members are informed and voluntarily sign the informed consent;

Who cannot join

  • The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.;
  • Thalamic hemorrhage, primary ventricular hemorrhage;
  • Platelet count <100×109/L, INR > 1.4;
  • Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery;
  • Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points;
  • Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days;
Show all 10Show fewer
  • Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required;
  • Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems;
  • Pregnant or breastfeeding women, or those who expect to become pregnant within one year;
  • are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).

Trial locations and contacts

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

Rong Hu, MD contact

8615123917123

huchrong@aliyun.com

Hua Feng, MD contact

8613708321681

fenghua201818@aliyun.com

China2 sites, 2 recruiting

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

    Rong Hu, MD, 8615123917123, huchrong@aliyun.com

    Recruiting

  • Dazhu County People's Hospital

    Dazhou, Sichuan, 635100

    Sheng Zhu, MD, +8615882911301, 371773434@qq.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage: a Multicenter, Randomized, Controlled Clinical Trial

This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.

Read the detailed description

Previous retrospective studies have demonstrated that neuroendoscopic surgery, compared to conventional craniotomy, significantly reduces operative duration and intraoperative blood loss, enhances hematoma evacuation rates, and improves postoperative outcomes, including neurological recovery, activities of daily living, and quality of life in patients with large cerebral hemorrhage. However, there is a paucity of prospective randomized controlled trials evaluating the efficacy of different surgical techniques for intracerebral hemorrhage. To address this gap, the investigators propose a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of neuroendoscopic surgery versus craniotomy, aiming to provide evidence-based guidance for surgical decision-making in cerebral hemorrhage management.

Being tested
neuroendoscopic surgery, craniotomy
Keywords
intracerebral hemorrhage, neuroendoscopic, craniotomy
Medical subject headings
Cerebral Hemorrhage

What participants receive

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

  • neuroendoscopic surgeryProcedure or surgery

    Subjects will receive Neuroendoscopic Surgery followed by standard medical management

  • craniotomyProcedure or surgery

    Subjects will receive Craniotomy followed by standard medical management

Study groups in NCT06894433
Study groupRoleWhat they receive
Experimental ArmExperimentalNeuroendoscopic Surgery to remove intracranial hematoma
Receives: Procedure: neuroendoscopic surgery
Control ArmActive comparatorCraniotomy to remove intracranial hematoma
Receives: Procedure: craniotomy

What is being measured

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

  1. The proportion of patients with Modified Rankin Scale (mRS) score 0-3

    Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

    Measured: 180 days

Secondary outcomes (11)

  1. Modified Rankin Scale (mRS) Score

    The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

    Measured: 180 days

  2. mortality

    All cause mortality from onset to 180 days

    Measured: 30 days, 90 days and 180 days

  3. Glasgow Outcome Scale Extended (GOS-E)

    GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.

    Measured: 180 days

  4. Assessment of cognitive function with Mini-Mental State Examination (MMSE)

    The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function.

    Measured: 90 days and 180 days

  5. Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)

    The EQ-5D-5L is a standard measure of health-related quality of life.EQ-5D-5L consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health.

    Measured: 30 days and 180 days

  6. The proportion of patients with Modified Rankin Scale (mRS) score 0-2

    Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

    Measured: 180 days

  7. Length of ICU

    Duration of stay in the ICU

    Measured: Number of days from admission, up to 180 days

  8. Length of hospitalization

    Duration of stay in the hospital

    Measured: Number of days from admission to discharge, up to 180 days

  9. The proportion of patients with Modified Rankin Scale (mRS) score 0-3

    Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

    Measured: 30 days and 90 days

  10. Operation duration

    The length of the operation

    Measured: From the beginning to the end of the surgery

  11. Peroperative bleeding

    The amount of blood lost during surgery

    Measured: During surgery

Timeline

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

  1. First posted25 Mar 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (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
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06894433
Sponsor's protocol ID
Neurosurg 05
Acronym
NESICH 2
Status last verified
Mar 2025
First submitted
18 Mar 2025
Last updated
18 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beck J, Fung C, Strbian D, Butikofer L, Z'Graggen WJ, Lang MF, Beyeler S, Gralla J, Ringel F, Schaller K, Plesnila N, Arnold M, Hacke W, Juni P, Mendelow AD, Stapf C, Al-Shahi Salman R, Bressan J, Lerch S, Hakim A, Martinez-Majander N, Piippo-Karjalainen A, Vajkoczy P, Wolf S, Schubert GA, Hollig A, Veldeman M, Roelz R, Gruber A, Rauch P, Mielke D, Rohde V, Kerz T, Uhl E, Thanasi E, Huttner HB, Kallmunzer B, Jaap Kappelle L, Deinsberger W, Roth C, Lemmens R, Leppert J, Sanmillan JL, Coutinho JM, Hackenberg KAM, Reimann G, Mazighi M, Bassetti CLA, Mattle HP, Raabe A, Fischer U; SWITCH study investigators. Decompressive craniectomy plus best medical treatment versus best medical treatment alone for spontaneous severe deep supratentorial intracerebral haemorrhage: a randomised controlled clinical trial. Lancet. 2024 Jun 1;403(10442):2395-2404. doi: 10.1016/S0140-6736(24)00702-5. Epub 2024 May 15.

    PubMed 38761811

  • Pradilla G, Ratcliff JJ, Hall AJ, Saville BR, Allen JW, Paulon G, McGlothlin A, Lewis RJ, Fitzgerald M, Caveney AF, Li XT, Bain M, Gomes J, Jankowitz B, Zenonos G, Molyneaux BJ, Davies J, Siddiqui A, Chicoine MR, Keyrouz SG, Grossberg JA, Shah MV, Singh R, Bohnstedt BN, Frankel M, Wright DW, Barrow DL; ENRICH trial investigators; ENRICH Trial Investigators. Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med. 2024 Apr 11;390(14):1277-1289. doi: 10.1056/NEJMoa2308440.

    PubMed 38598795

  • Correction to: ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial. Stroke. 2017 Nov;48(11):e335. doi: 10.1161/STR.0000000000000153. No abstract available.

    PubMed 29061841

  • Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.

    PubMed 30739747

  • Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2022 Jul;53(7):e282-e361. doi: 10.1161/STR.0000000000000407. Epub 2022 May 17. No abstract available.

    PubMed 35579034

  • Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.

    PubMed 26022637

  • Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet. 2005 Jan 29-Feb 4;365(9457):387-97. doi: 10.1016/S0140-6736(05)17826-X.

    PubMed 15680453

  • Teo KC, Fong SM, Leung WCY, Leung IYH, Wong YK, Choi OMY, Yam KK, Lo RCN, Cheung RTF, Ho SL, Tsang ACO, Leung GKK, Chan KH, Lau KK. Location-Specific Hematoma Volume Cutoff and Clinical Outcomes in Intracerebral Hemorrhage. Stroke. 2023 Jun;54(6):1548-1557. doi: 10.1161/STROKEAHA.122.041246. Epub 2023 May 22.

    PubMed 37216445

  • Broderick JP, Brott TG, Duldner JE, Tomsick T, Huster G. Volume of intracerebral hemorrhage. A powerful and easy-to-use predictor of 30-day mortality. Stroke. 1993 Jul;24(7):987-93. doi: 10.1161/01.str.24.7.987.

    PubMed 8322400

  • Sondag L, Schreuder FHBM, Boogaarts HD, Rovers MM, Vandertop WP, Dammers R, Klijn CJM; Dutch ICH Surgery Trial Study Group, part of the CONTRAST consortiumdagger. Neurosurgical Intervention for Supratentorial Intracerebral Hemorrhage. Ann Neurol. 2020 Aug;88(2):239-250. doi: 10.1002/ana.25732. Epub 2020 Apr 30.

    PubMed 32239722

  • Ma L, Hu X, Song L, Chen X, Ouyang M, Billot L, Li Q, Malavera A, Li X, Munoz-Venturelli P, de Silva A, Thang NH, Wahab KW, Pandian JD, Wasay M, Pontes-Neto OM, Abanto C, Arauz A, Shi H, Tang G, Zhu S, She X, Liu L, Sakamoto Y, You S, Han Q, Crutzen B, Cheung E, Li Y, Wang X, Chen C, Liu F, Zhao Y, Li H, Liu Y, Jiang Y, Chen L, Wu B, Liu M, Xu J, You C, Anderson CS; INTERACT3 Investigators. The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial. Lancet. 2023 Jul 1;402(10395):27-40. doi: 10.1016/S0140-6736(23)00806-1. Epub 2023 May 25.

    PubMed 37245517

  • Pinho J, Costa AS, Araujo JM, Amorim JM, Ferreira C. Intracerebral hemorrhage outcome: A comprehensive update. J Neurol Sci. 2019 Mar 15;398:54-66. doi: 10.1016/j.jns.2019.01.013. Epub 2019 Jan 14.

    PubMed 30682522

  • van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.

    PubMed 20056489

  • GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

    PubMed 30871944

Questions about this trial

What is this clinical trial studying?

A study testing neuroendoscopic surgery and craniotomy in people with Intracerebral Haemorrhage, run by Southwest Hospital, China at 2 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 7 inclusion and 10 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 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Rong Hu, MD (8615123917123, huchrong@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with Modified Rankin Scale (mRS) score 0-3 (time frame: 180 days). 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 NCT06894433, which also lists 14 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 18 May 2025.

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