Back to resultsThe Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH (BIATICH)
Primary Purpose
Cerebral Hemorrhage, Hypertensive, Bioelectrical Impedance Analysis, Intracranial Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Non-invasive intracranial pressure monitoring
Parenchymal Intracranial pressure monitor
Treatment based on clinical and imaging observations
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Hemorrhage, Hypertensive focused on measuring Spontaneous cerebral hemorrhage, Brain Edema, Bioelectrical impedance analysis, Intracranial Hypertension, Non-invasive intracranial pressure monitoring, Massive intracerebral hemorrhage, Treatment Outcome
Eligibility Criteria
Inclusion Criteria:
- Age >18 years old and Age <80 years old.
- Diagnosed of a supratentorial spontaneous intracerebral hemorrhage.
- 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).
- Admission to study hospital within 48 hours of the disease.
- The family signed the informed consent.
Exclusion Criteria:
- 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.)
- the presence of fixed bilateral dilated pupils on admission, no recovery of pupils after initial dehydration treatment, and very poor survival
- 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
- patients who are pregnant or lactating.
- patients with bilateral temporal skin ulceration, or subcutaneous hematoma in which monitoring electrode placement cannot be implemented
- 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.)
- the patient is agitated, coughing or choking too frequently, unable to be sedated or has difficulty in handling.
- those with mRS score > 2 before this onset.
Sites / Locations
- Brain Hospital of Hunan Province
- Changsha Eighth Hospital(Changsha Hospital of Traditional Chinese Medicine)
- Changsha Fourth Hospital
- Hunan Provincial People's Hospital
- The Third Xiangya Hospital of Central South University
- XiangYa School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Bioelectrical impedance analysis(BIA) monitoring
ICP monitoring
Usual Care
Arm Description
Care based upon intracranial pressure and cerebral edema.
Care based upon intracranial pressure.
Treatment based on clinical and imaging without intracranial pressure monitoring.
Outcomes
Primary Outcome Measures
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.
Long-term outcome measures of neurological disability . mRS, NIHSS and Extended Glasgow Outcome Scale score.
Secondary Outcome Measures
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Correlation of edema quantification features
Comparison of the trend of brain edema coefficients monitored by the BIA technique with the quantitative features of 3D-Slice edema on CT images.
Modified Rankin scale
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after ICH，good prognosis (mRS score 0-2), generally good prognosis (mRS score 3-4) , Poor prognosis (mRS >4 points).
Duration of ICU treatment
Time from the start of patient randomization to stable transfer out of the ICU.
GOS-E score
The difference value of the GOS-E between Day 14/Day 90，was used to evaluate the functional outcomes after ICH.
Quality of life score (EQ-5D)
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Length of hospitalization
Length of stay of patients throughout the treatment period since randomization.
The incidence of serious adverse events
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
Total mortality
All deaths reported post-randomization will be recorded and adjudicated
Adverse Events
The percentage of the Adverse Events during the therapy.
Severity Adverse Event
The percentage of the Severity Adverse Events within the 14 days of the therapy.
Total mortality
All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
Adverse Events
The percentage of the Adverse Events during the therapy.
The incidence of adverse events That are related to treatment
Incidence of complications that occurred during the use of invasive ICP or noninvasive cerebral edema monitoring after patient randomization. such as intracranial infection, probe displacement, recurrent intracranial hemorrhage, skin infection, etc.
Full Information
NCT ID
NCT05593380
First Posted
October 20, 2022
Last Updated
October 20, 2022
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05593380
Brief Title
The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH
Acronym
BIATICH
Official Title
The Effect of BIA Monitoring of Brainedemaontheneurological Prognosis of Supratentorial Massive Intracerebral Hemorrhage - A Randomized, Contrast，Multi-center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2022 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 <30 ml was 19% and that of >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 commonly used neurological monitoring modalities in neurocritical conditions worldwide. There remains uncertainty in the prognosis of neurological function in patients with traumatic and non-traumatic brain injury with invasive intracranial pressure monitoring, non-invasive intracranial pressure monitoring and cerebral edema monitoring modalities, and differences in clinical practice between the two tests in patients with large volume cerebral hemorrhage. The objectives of this study were to explore the differences between non-invasive brain edema monitoring based on BIA technology (Chongqing Born-Fruk Medical Equipment Co., Ltd., Chongqing, China) and invasive intracranial pressure monitoring, and whether non-invasive brain edema monitoring based on BIA technology is more beneficial for the long-term prognosis of patients with episodic large-volume cerebral hemorrhage, whether there are fewer complications, and whether such monitoring measures are more acceptable in clinical practice. The trial is a prospective, randomized, open-label, controlled, multi-clinical center trial; the sample size was calculated based on previous studies to include a total of approximately 776 cases, and is expected to include more than 20 clinical institutions with extensive experience in the treatment of large volume cerebral hemorrhage in Hunan Province, China. Patients diagnosed with supratentorial parenchymal cerebral hemorrhage (hemorrhage volume ≥ 30 ml according to the Coniglobus formula ) by CT examination within 48 hours of onset were included, and informed consent was provided to patients who met the enrollment criteria. The included cases were divided into surgical and non-surgical groups according to the guidelines for the treatment of cerebral hemorrhage and taking into account the patient's condition, the physician's decision and the family's choice of whether to receive surgical treatment (craniotomy or minimally invasive surgery) or conservative treatment, thus avoiding the ethical risk of large-volume cerebral hemorrhage. Enrolled non-surgical cases were randomly assigned 1:1 to the BIA non-invasive cerebral edema monitoring group and theImaging clinical examination（ICE) group. Cases that received surgical treatment were divided into two subgroups, the craniotomy group and the minimally invasive surgery group, depending on the type of surgery received, and of the two subgroups were randomly assigned in a 1 : 1 : 1 ratio to the invasive ICP monitoring group, the BIA technique noninvasive brain edema monitoring group, and the Imaging clinical examination（ICE） group. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Xiangya Hospital Central South Uniersity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hemorrhage, Hypertensive, Bioelectrical Impedance Analysis, Intracranial Hypertension, Monitoring, Critical Care, Treatment Outcome
Keywords
Spontaneous cerebral hemorrhage, Brain Edema, Bioelectrical impedance analysis, Intracranial Hypertension, Non-invasive intracranial pressure monitoring, Massive intracerebral hemorrhage, Treatment Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
776 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bioelectrical impedance analysis(BIA) monitoring
Arm Type
Experimental
Arm Description
Care based upon intracranial pressure and cerebral edema.
Arm Title
ICP monitoring
Arm Type
Active Comparator
Arm Description
Care based upon intracranial pressure.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Treatment based on clinical and imaging without intracranial pressure monitoring.
Intervention Type
Device
Intervention Name(s)
Non-invasive intracranial pressure monitoring
Other Intervention Name(s)
low-frequency, bioelectrical, noninvasive brain edema monitor (Chongqing Born-Fruk Medical Equipment Co. Ltd, Chongqing, China
Intervention Description
Treatment based on readings from Bioelectrical impedance analysis monitor（intracranial pressure and perturbation index (PI)）.
Intervention Type
Other
Intervention Name(s)
Parenchymal Intracranial pressure monitor
Other Intervention Name(s)
Integra Life Sciences Camino Intracranial Monitor
Intervention Description
Treatment based on readings from Parenchymal intracranial pressure monitor.
Intervention Type
Other
Intervention Name(s)
Treatment based on clinical and imaging observations
Intervention Description
Treatment based on clinical and imaging observations.
Primary Outcome Measure Information:
Title
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.
Description
Long-term outcome measures of neurological disability . mRS, NIHSS and Extended Glasgow Outcome Scale score.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Neurological recovery
Description
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Time Frame
90 days
Title
Correlation of edema quantification features
Description
Comparison of the trend of brain edema coefficients monitored by the BIA technique with the quantitative features of 3D-Slice edema on CT images.
Time Frame
14 days
Title
Modified Rankin scale
Description
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after ICH，good prognosis (mRS score 0-2), generally good prognosis (mRS score 3-4) , Poor prognosis (mRS >4 points).
Time Frame
90 days
Title
Duration of ICU treatment
Description
Time from the start of patient randomization to stable transfer out of the ICU.
Time Frame
90 days
Title
GOS-E score
Description
The difference value of the GOS-E between Day 14/Day 90，was used to evaluate the functional outcomes after ICH.
Time Frame
90 days
Title
Quality of life score (EQ-5D)
Description
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Time Frame
90 days
Title
Length of hospitalization
Description
Length of stay of patients throughout the treatment period since randomization.
Time Frame
90 days
Title
The incidence of serious adverse events
Description
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
Time Frame
90 days
Title
Total mortality
Description
All deaths reported post-randomization will be recorded and adjudicated
Time Frame
90 days
Title
Adverse Events
Description
The percentage of the Adverse Events during the therapy.
Time Frame
90 days
Title
Severity Adverse Event
Description
The percentage of the Severity Adverse Events within the 14 days of the therapy.
Time Frame
14 days
Title
Total mortality
Description
All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
Time Frame
14 days
Title
Adverse Events
Description
The percentage of the Adverse Events during the therapy.
Time Frame
14 days
Title
The incidence of adverse events That are related to treatment
Description
Incidence of complications that occurred during the use of invasive ICP or noninvasive cerebral edema monitoring after patient randomization. such as intracranial infection, probe displacement, recurrent intracranial hemorrhage, skin infection, etc.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years old and Age <80 years old.
Diagnosed of a supratentorial spontaneous intracerebral hemorrhage.
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).
Admission to study hospital within 48 hours of the disease.
The family signed the informed consent.
Exclusion Criteria:
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.)
the presence of fixed bilateral dilated pupils on admission, no recovery of pupils after initial dehydration treatment, and very poor survival
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
patients who are pregnant or lactating.
patients with bilateral temporal skin ulceration, or subcutaneous hematoma in which monitoring electrode placement cannot be implemented
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.)
the patient is agitated, coughing or choking too frequently, unable to be sedated or has difficulty in handling.
those with mRS score > 2 before this onset.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Le, PhD
Phone
13973187150
Email
zlzdzlzd@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Xiangbin
Phone
13875962704
Email
zhagnxiangbin25@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Le, PhD
Organizational Affiliation
Department of Neurology，XiangYa School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Hospital of Hunan Province
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Kun, PhD
Facility Name
Changsha Eighth Hospital(Changsha Hospital of Traditional Chinese Medicine)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Changsha Fourth Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
XiangYa School of Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Xiangbin
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://rs.yiigle.com/CN112137201709/972019.htm
Description
Chinese Expert Consensus on Monitoring and Treatment of Spontaneous Large Volume Cerebral Hemorrhage
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDZHYX&filename=ZHCS201708016&uniplatform=NZKPT&v=OTLqMwQkzJB53apyj50gXP473ZTeWwtlkohToiHUng0eDpXbcih6qYcsaWiYBAnL
Description
An applied research on non-invasive and dynamic monitor of cerebral edema in patients after craniotomy
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CMFD&dbname=CMFD2009&filename=2009064300.nh&uniplatform=NZKPT&v=AOpPQzQDMl-VJZ8H-KWRPhyaLhowckOyadDTtb6G6erEL1sKBd34MTJGx9FpqcTE
Description
Trunk subdivision bioelectrical impedance analysis of body composition
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2001&filename=YXWZ200101009&uniplatform=NZKPT&v=lVYC_AMvNqB4o4X1tQ7L22y6HQGl7QDAAN-b_0AR5SZ-brjNXnUXclpt3iEgQyuQ
Description
Disturbance method of electric current field and its application in impedance imaging
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2003&filename=ZHYX200306008&uniplatform=NZKPT&v=CAr8b2wwr3b7L8O8NxFHAC2KFXMdVrX51LitXvBPRsgejq8CVaMuVgwKAK8QInbv
Description
Noninvasive monitoring of hypertensive intracerebral hemorrhage and perihematomal tissue edema
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2007&filename=ZHSJ200706007&uniplatform=NZKPT&v=rxlfgEeP_kUAcTBIbfqYfRPuuVNEEzR8G9G4CfqzrNblOUph8Lyhw1BDdd6rlNpd
Description
Application of noninvasive cerebral electrical impedance measurement on brain edema in patients with intracerebral hemorrhage
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CMFD&dbname=CMFD2010&filename=2010015764.nh&uniplatform=NZKPT&v=DZRsncyRWA-kDLE22rWY3SxXwHUbJSHInOPpMy4EgV2S9hjIL3368SpaJS0wzZ_N
Description
A new method of noninvasive brain-edema monitoring in patients with intracranial tumor: cerebral electrical impedance measurement
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2011&filename=LXYB201103016&uniplatform=NZKPT&v=pBUGsByuDjfeeKsmumQdEjnXla7Ybu3xGwem1DHVPYsNvIFvVN6_9ZbGPG2T4Gyd
Description
An applied research on non-invasive and dynamic monitor of cerebral edema in patients after craniotomy
URL
https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2012&filename=ZWQX201208005&uniplatform=NZKPT&v=qSCtlduJ1C_UjPQ_SJCYNecS2t62VxY_NmKKhHtDKo_LVmcFT8FYVnJJ2JKxP-cz
Description
Application of continuous intracranial pressure monitoring in hypertensive cerebral hemorrhge
Learn more about this trial
The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH
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