Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage

NCT05539859 | Recruiting DMC

• 1 other identifier: (A)KY2022103
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 4

Brief Summary

To compare the efficacy and safety of neuroendoscopic hematoma removal and standard conservative treatment for patients with spontaneous supratentorial deep intracerebral hemorrhage.

Conditions

Intracerebral Hemorrhage Basal Ganglia

Keywords

Intracerebral hemorrhage; NeuroEndoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  180 days

• Safety outcome

  All cause mortality from onset to 180 days

  180 days

Secondary Outcomes (16)

• Glasgow Outcome Scale Extended (GOS-E)

  30 days.

• Glasgow Outcome Scale Extended (GOS-E)

  90 days.

• Glasgow Outcome Scale Extended (GOS-E)

  180 days.

• Modified Rankin Scale (mRS) Score

  30 days.

• Modified Rankin Scale (mRS) Score

  90 days .

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Endoscopic surgery

Procedure: Endoscopic surgery

Control Arm

ACTIVE COMPARATOR

Medical management

Other: Medical management

Interventions

Endoscopic surgery PROCEDURE

Subjects will receive surgical hematoma evacuation using neuroendoscope, followed by medical management

Experimental Arm

Medical management OTHER

Subjects will initially receive the standard medical therapies for the treatment of intracerebral hemorrhage, according to the latest available guideline.

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, either sex.
• Time from onset to the first diagnostic CT within 24 hours (for those without bystanders and with unknown onset time, use the last known time the patient was in good condition)
• Deep (external capsule, putamen, internal capsule, caudate nucleus) supratentorial cerebral hemorrhage with a hematoma volume ≥ 25 ml.
• Stability of the hematoma determined by two CT scans at different times after onset. If the hematoma enlarges 5ml then the stability of the hematoma can be detected by CT again after 6 hours until the randomization time window is closed.
• Pre-randomization GCS score of 5-14 and/or NIHSS score of ≥6.
• Pre-onset Modified Rankin Scale (mRS) score 0 or 1.
• Blood pressure recorded 6 hours prior to randomization consistently controlled at 180 mmHg or less.
• Randomization completed within 24 hours after the first diagnostic CT, and surgical intervention should be performed as soon as possible, no later than 6 hours after randomization, that is to say, surgery should be performed no later than 54 hours after onset.
• Informed and voluntarily signed informed consent by the patient or family.

You may not qualify if:

• Hemorrhage clinically diagnosed as a result of cerebral aneurysm, cerebrovascular malformation, moyamoya disease, traumatic brain injury, brain tumor, hemorrhagic transformation of a large cerebral infarct, coagulation dysfunction.
• Lobar hemorrhages, thalamic hemorrhages, primary ventricular hemorrhages, cerebellum hemorrhages and brain stem hemorrhages.
• Hematoma involving the midbrain, with dilated or unresponsive pupils.
• Hematoma producing life-threatening occupying effects (e.g., CT showing midline deviation of more than 1 cm, loss of cisterna ambiens) or patients who are extremely unstable and unfit for enrollment.
• Platelet count \<100×10\^9/L, international normalized ratio (INR) \>1.4.
• Hematoma extension to ventricle and completely blocked the third or fourth ventricle.
• Recent history of cerebral hemorrhage (less than 1 year).
• Severe hepatic impairment with ALT 3 times the upper limit of normal, or AST 3 times the upper limit of normal. Severe renal insufficiency with glomerular filtration rate less than 30 ml/min/1.73 m2.
• Blood pressure not effectively controlled to less than 180 mmHg despite aggressive antihypertensive therapy prior to randomization.
• Patients with severe advanced cognitive impairment (e.g. AD) or psychiatric disorders who are unable to complete the follow-up program as required.
• Comorbid other serious diseases such as respiratory, circulatory, digestive, urological, endocrine, immune and hematologic disorders.
• Pregnant or lactating women, or those who expect to become pregnant within one year.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (4)

chongqing Emergency Medical Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Xiang Yang NO.1 Peoples Hospital

Hubei, Hubei, 441000, China

RECRUITING

Dazhu County People's Hospital

Sichuan, Sichuan, 635100, China

RECRUITING

Ganzhou city people's Hospita

Ganzhou, China

RECRUITING

Related Publications (7)

• Hansen BM, Ullman N, Muschelli J, Norrving B, Dlugash R, Avadhani R, Awad I, Zuccarello M, Ziai WC, Hanley DF, Thompson RE, Lindgren A; MISTIE and CLEAR Investigators. Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III. Neurocrit Care. 2020 Oct;33(2):516-524. doi: 10.1007/s12028-020-00916-4.

  PMID: 32026447 BACKGROUND

• de Oliveira Manoel AL. Surgery for spontaneous intracerebral hemorrhage. Crit Care. 2020 Feb 7;24(1):45. doi: 10.1186/s13054-020-2749-2.

  PMID: 32033578 BACKGROUND

• Anderson CD, James ML. Survival and independence after intracerebral hemorrhage: Trends and opportunities. Neurology. 2018 Jun 5;90(23):1043-1044. doi: 10.1212/WNL.0000000000005625. Epub 2018 May 4. No abstract available.

  PMID: 29728523 BACKGROUND

• Kuo LT, Chen CM, Li CH, Tsai JC, Chiu HC, Liu LC, Tu YK, Huang AP. Early endoscope-assisted hematoma evacuation in patients with supratentorial intracerebral hemorrhage: case selection, surgical technique, and long-term results. Neurosurg Focus. 2011 Apr;30(4):E9. doi: 10.3171/2011.2.FOCUS10313.

  PMID: 21456936 BACKGROUND

• Kellner CP, Song R, Pan J, Nistal DA, Scaggiante J, Chartrain AG, Rumsey J, Hom D, Dangayach N, Swarup R, Tuhrim S, Ghatan S, Bederson JB, Mocco J. Long-term functional outcome following minimally invasive endoscopic intracerebral hemorrhage evacuation. J Neurointerv Surg. 2020 May;12(5):489-494. doi: 10.1136/neurintsurg-2019-015528. Epub 2020 Jan 8.

  PMID: 31915207 BACKGROUND

• Xu X, Chen X, Li F, Zheng X, Wang Q, Sun G, Zhang J, Xu B. Erratum. Effectiveness of endoscopic surgery for supratentorial hypertensive intracerebral hemorrhage: a comparison with craniotomy. J Neurosurg. 2018 Feb;128(2):649. doi: 10.3171/2017.5.JNS161589a. Epub 2017 Jul 28. No abstract available.

  PMID: 28753114 BACKGROUND

• Wang L, Zhou T, Wang P, Zhang S, Yin Y, Chen L, Duan H, Wu N, Feng H, Hu R. Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: A randomized, controlled, open-label, blinded endpoint trial (NESICH). Int J Stroke. 2024 Jun;19(5):587-592. doi: 10.1177/17474930241232292. Epub 2024 Feb 19.

  PMID: 38291017 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Endoscopy; Practice Management, Medical

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Rong Hu, MD

  PLA Army Medical University

  STUDY CHAIR

Central Study Contacts

Rong Hu, MD

CONTACT

8615123917123; huchrong@aliyun.com

Hua Feng, MD

CONTACT

8613708321681; fenghua201818@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Neurosurgery

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 14, 2022
• Study Start: November 18, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)