Clinical trial NCT05593380: The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH
Official title: The Effect of BIA Monitoring of Brainedemaontheneurological Prognosis of Supratentorial Massive Intracerebral Hemorrhage - A Randomized, Contrast，Multi-center Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Hemorrhage, Hypertensive
Intracranial Hypertension
Monitoring
Critical Care
Treatment Outcome
Invasive Intracranial Pressure Monitoring
Large-volume Cerebral Hemorrhage
Keywords: Spontaneous cerebral hemorrhage
Brain Edema
Intracranial Hypertension
Non-invasive intracranial pressure monitoring
Massive intracerebral hemorrhage
Treatment Outcome
invasive intracranial pressure monitoring
Large-volume cerebral hemorrhage
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 190
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: Spontaneous cerebral hemorrhage (SICH) is a hemorrhage caused by the rupture of a blood vessel within the brain parenchyma that is non-traumatic. Its rapid onset and dangerous condition seriously threaten human health; it accounts for about 15% of strokes and 50% of stroke-related mortality. Hunan Province is recognized as one of the high incidence areas of cerebral hemorrhage in the world; according to statistics, the direct economic loss caused by cerebral hemorrhage in Hunan Province is more than 1 billion yuan per year, which should be paid great attention. A 30-day follow-up study of large-volume cerebral hemorrhage (defined as supratentorial hemorrhage greater than 30 ml, infratentorial greater than 5 ml, and thalamus and cerebellum greater than 15 ml) found that the morbidity and mortality rate of ICH with hemorrhage of 30-60 ml was as high as 44-74%, while the morbidity and mortality rate of ICH with hemorrhage of \&lt;30 ml was 19% and that of \&gt;60 ml was 91%. According to studies, the occurrence of hematoma occupancy and malignant cerebral edema in large-volume cerebral hemorrhage can lead to secondary malignant intracranial pressure elevation and subsequent secondary brain injury, which are the main factors of high morbidity and mortality and poor prognosis in patients with large-volume cerebral hemorrhage. Clinical monitoring and management is the key to treatment, and despite aggressive surgical treatment and anti-brain edema therapy, a large number of patients progress to malignant brain edema disease, leading to poor outcomes. Therefore, this project intends to conduct a multicenter clinical trial of non-invasive monitoring of large volume cerebral hemorrhage on the curtain in the Hunan region to explore the impact of non-invasive brain edema monitoring management based on bioelectrical impedance technology on patient prognosis; and to explore early biomarkers of malignant brain edema through metabolomic analysis and the mechanism of malignant brain edema occurrence through multi-omic analysis to provide data support for the clinical treatment application of malignant brain edema.

Detailed description: Intracranial pressure and cerebral edema monitoring are widely employed modalities of neurological assessment in neurocritical care patients globally. However, uncertainties remain regarding the prognostic value of invasive and noninvasive intracranial pressure monitoring and cerebral edema monitoring techniques on neurological function in patients with both traumatic and non-traumatic brain injuries. Additionally, clinical practices for these modalities vary significantly in patients with extensive cerebral hemorrhage. This study aims to determine whether continuous ambulatory monitoring of intracranial pressure, administered postoperatively to patients with large-volume cerebral hemorrhage, can enhance overall prognosis by guiding adjustments in brain-specific therapeutic intensity and reducing early mortality within 14 days. The study is designed as a prospective, open-label, randomized, controlled, multi-center trial with a sample size estimated based on the efficacy observed in prior research, encompassing approximately 190 cases across 15-20 clinical institutions in China experienced in treating large-volume cerebral hemorrhage. The study population consists of patients diagnosed with significant supraventricular cerebral hemorrhage (≥30 ml, based on the Coniglobus formula) via CT examination within 48 hours of symptom onset. Informed consent was obtained from patients who met the eligibility criteria. Ethical risks associated with high-volume cerebral hemorrhage were mitigated by offering surgical treatment (either open debridement flap or endoscopic hematoma removal) in accordance with established guidelines and consideration of the patient\&#39;s condition, the physician\&#39;s judgment, and the family\&#39;s preferences. Enrolled participants were randomly assigned in a 1:1 ratio to either the invasive intracranial pressure monitoring group or the imaging-clinical examination (ICE) group. All relevant research organizations and personnel will adhere to the Declaration of Helsinki and the Chinese Standards of Good Clinical Practice. This trial has received approval from the Institutional Review Board (IRB) and Ethics Committee (EC) of Xiangya Hospital, Central South University.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years old and Age \<80 years old.
2. Diagnosed of a supratentorial spontaneous intracerebral hemorrhage.
3. Diagnosis of supratentorial large-volume cerebral hemorrhage by CT or other imaging and meeting the diagnostic criteria for large-volume cerebral hemorrhage(hemorrhage volume ≥ 30 mL of supratentorial cerebral parenchymal hematoma volume according to the Coniglobus formula on the first CT scan at onset).
4. Admission to study hospital within 48 hours of the disease.
5. The family signed the informed consent.

Exclusion Criteria:

1. traumatic cerebral hemorrhage, cerebral amyloid angiopathy(CAA), secondary cerebral hemorrhage due to other specific etiologies (aneurysm, vascular malformation, smoker's disease, coagulopathy, aneurysmal stroke, vasculitis, cerebral venous thrombosis, hemorrhagic cerebral infarction, etc.)
2. the presence of fixed bilateral dilated pupils on admission, no recovery of pupils after initial dehydration treatment, and very poor survival
3. patients with extremely unstable vital signs after admission, with extremely poor prognosis and those considered non-viable, and patients whose families have abandoned follow-up treatment
4. patients who are pregnant or lactating.
5. patients with bilateral temporal skin ulceration, or subcutaneous hematoma in which monitoring electrode placement cannot be implemented
6. the presence of other serious underlying diseases (intractable hypoxemia and circulatory failure with cardiopulmonary insufficiency that is difficult to correct by treatment, severe abnormal coagulation, severely reduced platelets, severe hepatic and renal insufficiency, combined neurodegenerative diseases, psychiatric diseases, autoimmune diseases, malignant tumors, thyroid diseases, etc.)
7. the patient is agitated, coughing or choking too frequently, unable to be sedated or has difficulty in handling.
8. those with mRS score \> 2 before this onset.

Primary outcomes:
measure: In a randomized controlled trial, test the effect on outcomes of management of severe supratentorial massive intracerebral hemorrhage guided by information from BIA monitors vs. ICP monitors and a standard empiric protocol.
timeFrame: 90 days
Secondary outcomes:
measure: Neurological recovery
timeFrame: 90 days
measure: Modified Rankin scale
timeFrame: 90 days
measure: Duration of ICU treatment
timeFrame: 90 days
measure: GOS-E score
timeFrame: 90 days
measure: Quality of life score (EQ-5D)
timeFrame: 90 days
measure: Length of hospitalization
timeFrame: 90 days
measure: The incidence of serious adverse events
timeFrame: 90 days
measure: Total mortality
timeFrame: 90 days
measure: Adverse Events
timeFrame: 90 days
measure: Severity Adverse Event
timeFrame: 14 days
measure: Total mortality
timeFrame: 14 days
measure: Adverse Events
timeFrame: 14 days
measure: The incidence of adverse events That are related to treatment
timeFrame: 90 days
Other outcomes:
Locations:
city: Changde
country: China
facility: The First People's Hospital of Changde
state: Hunan
city: Changsha
country: China
facility: Changsha Fourth Hospital
state: Hunan
city: Changsha
country: China
facility: XiangYa School of Medicine
state: Hunan
city: Changsha
country: China
facility: Zhangjiajie People's Hospital
state: Hunan
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital)
state: Hunan
city: Chenzhou
country: China
facility: Chenzhou First People's Hospital
state: Hunan
city: Huaihua
country: China
facility: Hunan University of Medicine Hospital
state: Hunan
city: Shaoyang
country: China
facility: The Central Hospital of Shaoyang
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Yongzhou
country: China
facility: The Central Hospital of Yongzhou
state: Hunan
city: Yueyang
country: China
facility: Yueyang Central Hospital
state: Hunan
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Chengdu
country: China
facility: Chengdu Fifth Pepole's Hospital
state: Sichuan
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
Study officials:
affiliation: Department of Neurology，XiangYa School of Medicine
name: Zhang Le, PhD
role: PRINCIPAL_INVESTIGATOR
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