Clinical trial NCT05539859: Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage
Official title: Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: a Randomised, Controlled, Open-label, Blinded Endpoint Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracerebral Hemorrhage Basal Ganglia
Keywords: Intracerebral hemorrhage
NeuroEndoscopic Surgery
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Neuroendoscopic treatment of spontaneous intracerebral hemorrhage (ICH) is more and more widely used, but multi-center clinical study on the efficacy and safety of neuroendoscopic treatment of ICH is relatively small. Based on the lack of sufficient clinical evidence, the investigators plan to conduct a prospective, multicenter, randomized controlled clinical trial to investigate the safety and efficacy of neuroendoscopy in the treatment of spontaneous cerebral parenchymal hemorrhage, so as to provide evidence-based medical evidence for endoscopic minimally invasive treatment of cerebral hemorrhage and its application.The aim of trial was to determine whether the endoscopic surgery could achieve the benefits of clot evacuation and improve functional outcome at 180 days after ICH without procedure-related safety events or additional brain injury beyond the risks associated with standard care

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years, either sex.
2. 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)
3. Deep (external capsule, putamen, internal capsule, caudate nucleus) supratentorial cerebral hemorrhage with a hematoma volume ≥ 25 ml.
4. 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.
5. Pre-randomization GCS score of 5-14 and/or NIHSS score of ≥6.
6. Pre-onset Modified Rankin Scale (mRS) score 0 or 1.
7. Blood pressure recorded 6 hours prior to randomization consistently controlled at 180 mmHg or less.
8. 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.
9. Informed and voluntarily signed informed consent by the patient or family.

Exclusion Criteria:

1. 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.
2. Lobar hemorrhages, thalamic hemorrhages, primary ventricular hemorrhages, cerebellum hemorrhages and brain stem hemorrhages.
3. Hematoma involving the midbrain, with dilated or unresponsive pupils.
4. 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.
5. Platelet count \<100×10\^9/L, international normalized ratio (INR) \>1.4.
6. Hematoma extension to ventricle and completely blocked the third or fourth ventricle.
7. Recent history of cerebral hemorrhage (less than 1 year).
8. 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.
9. Blood pressure not effectively controlled to less than 180 mmHg despite aggressive antihypertensive therapy prior to randomization.
10. Patients with severe advanced cognitive impairment (e.g. AD) or psychiatric disorders who are unable to complete the follow-up program as required.
11. Comorbid other serious diseases such as respiratory, circulatory, digestive, urological, endocrine, immune and hematologic disorders.
12. Pregnant or lactating women, or those who expect to become pregnant within one year.

Primary outcomes:
measure: The proportion of patients with Modified Rankin Scale (mRS) score 0-3
timeFrame: 180 days
measure: Safety outcome
timeFrame: 180 days
Secondary outcomes:
measure: Glasgow Outcome Scale Extended (GOS-E)
timeFrame: 30 days.
measure: Glasgow Outcome Scale Extended (GOS-E)
timeFrame: 90 days.
measure: Glasgow Outcome Scale Extended (GOS-E)
timeFrame: 180 days.
measure: Modified Rankin Scale (mRS) Score
timeFrame: 30 days.
measure: Modified Rankin Scale (mRS) Score
timeFrame: 90 days .
measure: Survival rate
timeFrame: 30 days.
measure: Survival rate
timeFrame: 90 days.
measure: Assessment of cognitive function with Mini-Mental State Examination (MMSE)
timeFrame: 30 days.
measure: Assessment of cognitive function with Mini-Mental State Examination (MMSE)
timeFrame: 90 days.
measure: Assessment of cognitive function with Mini-Mental State Examination (MMSE)
timeFrame: 180 days.
measure: Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)
timeFrame: 30 days.
measure: Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)
timeFrame: 90 days.
measure: Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)
timeFrame: 180 days.
measure: Length of ICU
timeFrame: Number of days from admission, up to 180 days
measure: Length of hospitalization
timeFrame: Number of days from admission to discharge, up to 180 days
measure: In-hospital cost
timeFrame: Number of days from admission to discharge, up to 180 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: chongqing Emergency Medical Center
state: Chongqing
city: Hubei
country: China
facility: Xiang Yang NO.1 Peoples Hospital
state: Hubei
city: Sichuan
country: China
facility: Dazhu County People's Hospital
state: Sichuan
city: Ganzhou
country: China
facility: Ganzhou city people's Hospita
Study officials:
affiliation: PLA Army Medical University
name: Rong Hu, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: de Oliveira Manoel AL. Surgery for spontaneous intracerebral hemorrhage. Crit Care. 2020 Feb 7;24(1):45. doi: 10.1186/s13054-020-2749-2.
citation: 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.
citation: 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.
citation: 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.
citation: 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.