The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH (BIATICH)

October 20, 2022 updated by: Xiangya Hospital of Central South University

The Effect of BIA Monitoring of Brainedemaontheneurological Prognosis of Supratentorial Massive Intracerebral Hemorrhage - A Randomized, Contrast，Multi-center Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

776

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Brain Hospital of Hunan Province
        • Contact:
          • Liu Kun, PhD
      • Changsha, Hunan, China, 410008
        • Changsha Eighth Hospital(Changsha Hospital of Traditional Chinese Medicine)
      • Changsha, Hunan, China, 410008
        • Changsha Fourth Hospital
      • Changsha, Hunan, China, 410008
        • Hunan Provincial People's Hospital
      • Changsha, Hunan, China, 410008
        • The Third Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410008
        • XiangYa School of Medicine
        • Contact:
          • Zhang Xiangbin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioelectrical impedance analysis(BIA) monitoring
Care based upon intracranial pressure and cerebral edema.
Device: Non-invasive intracranial pressure monitoring
Treatment based on readings from Bioelectrical impedance analysis monitor（intracranial pressure and perturbation index (PI)）.
Other Names:
  • low-frequency, bioelectrical, noninvasive brain edema monitor (Chongqing Born-Fruk Medical Equipment Co. Ltd, Chongqing, China
Active Comparator: ICP monitoring
Care based upon intracranial pressure.
Other: Parenchymal Intracranial pressure monitor
Treatment based on readings from Parenchymal intracranial pressure monitor.
Other Names:
  • Integra Life Sciences Camino Intracranial Monitor
Other: Usual Care
Treatment based on clinical and imaging without intracranial pressure monitoring.
Other: Treatment based on clinical and imaging observations
Treatment based on clinical and imaging observations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 90 days
Long-term outcome measures of neurological disability . mRS, NIHSS and Extended Glasgow Outcome Scale score.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 90 days
The percentage of the Adverse Events during the therapy.
90 days
Severity Adverse Event
Time Frame: 14 days
The percentage of the Severity Adverse Events within the 14 days of the therapy.
14 days
Total mortality
Time Frame: 14 days
All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
14 days
Adverse Events
Time Frame: 14 days
The percentage of the Adverse Events during the therapy.
14 days
Neurological recovery
Time Frame: 90 days
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
90 days
Correlation of edema quantification features
Time Frame: 14 days
Comparison of the trend of brain edema coefficients monitored by the BIA technique with the quantitative features of 3D-Slice edema on CT images.
14 days
Modified Rankin scale
Time Frame: 90 days
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).
90 days
Duration of ICU treatment
Time Frame: 90 days
Time from the start of patient randomization to stable transfer out of the ICU.
90 days
GOS-E score
Time Frame: 90 days
The difference value of the GOS-E between Day 14/Day 90，was used to evaluate the functional outcomes after ICH.
90 days
Quality of life score (EQ-5D)
Time Frame: 90 days
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
90 days
Length of hospitalization
Time Frame: 90 days
Length of stay of patients throughout the treatment period since randomization.
90 days
The incidence of serious adverse events
Time Frame: 90 days
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
90 days
Total mortality
Time Frame: 90 days
All deaths reported post-randomization will be recorded and adjudicated
90 days
The incidence of adverse events That are related to treatment
Time Frame: 90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Zhang Le, PhD, Department of Neurology，XiangYa School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sjnkzhangle
  • 2018FY100900 (Other Identifier: Ministry of Science and Technology of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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