Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial

NCT ID: NCT05593380

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2025-07-28

Brief Summary

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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. This study aims to conduct a multicenter clinical trial in China investigating the role of invasive intracranial pressure (ICP) monitoring in managing patients with large-volume supratentorial intracerebral hemorrhage. The trial will evaluate whether ICP-guided treatment protocols for cerebral edema improve patient outcomes and generate evidence to support the clinical application of invasive ICP monitoring in this patient population.

Detailed Description

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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 mortality within 90 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 patients condition, the physicians judgment, and the familys 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.

Conditions

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Cerebral Hemorrhage, Hypertensive Intracranial Hypertension Monitoring Critical Care Treatment Outcome Invasive Intracranial Pressure Monitoring Large-volume Cerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ICP monitoring

Intracranial pressure monitoring equipment enables continuous dynamic monitoring of changes in intracranial pressure values. This technology reflects sudden shifts in intracranial pressure resulting from hemorrhage and other cranial conditions, allowing for timely adjustments in the intensity of cerebral therapeutic interventions.

Group Type EXPERIMENTAL

Parenchymal Intracranial pressure monitor

Intervention Type DEVICE

Treatment based on readings from Parenchymal intracranial pressure monitor.

imaging-clinical examination (ICE)

According to routine head CT imaging examinations, dynamic observations of changes in the patient's condition should be conducted. This involves closely monitoring clinical consciousness, pupil response, limb activity, and other clinical manifestations. Adjustments to the intensity of cerebral intervention should be made based on the clinical reflections of these dynamic changes.

Group Type OTHER

Treatment based on clinical and imaging observations

Intervention Type OTHER

Treatment based on clinical and imaging observations.

Interventions

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Parenchymal Intracranial pressure monitor

Treatment based on readings from Parenchymal intracranial pressure monitor.

Intervention Type DEVICE

Treatment based on clinical and imaging observations

Treatment based on clinical and imaging observations.

Intervention Type OTHER

Other Intervention Names

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Integra Life Sciences Camino Intracranial Monitor

Eligibility Criteria

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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. Participants were enrolled within 48 hours of symptom onset.
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.
9. Individuals unable to complete the follow-up phase of this trial due to psychiatric, cognitive, or emotional conditions;
10. Family members decline to provide informed consent.

Exit criteria:

1. Acute onset of other life-threatening illnesses identified as the primary cause of mortality;
2. Participants who voluntarily withdraw from the study before completion;
3. Participants deemed unsuitable for the trial's monitoring protocol post-enrollment;
4. Participants requiring a modification of the treatment plan post-enrollment due to medical reasons, resulting in compromised monitoring feasibility or significant deviations in monitoring accuracy that undermine the integrity of the final analysis.

Elimination criteria:

1. Participants who failed to record any data post-enrollment;
2. Participants who did not receive per-protocol treatment post-enrollment, were discharged within 72 hours, and had their families voluntarily withdraw informed consent;
3. Participants whose invasive intracranial pressure (ICP) monitoring probes shifted and were not promptly reinserted or calibrated, leading to excessive data errors precluding analysis;
4. Participants not receiving the invasive intracranial pressure (ICP) monitoring module according to their assigned group.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhang Le, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology,Xiangya Hospital, Central South University

Locations

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The First People's Hospital of Changde City (Changde Hospital, Xiangya School of Medicine, Central South University)

Changde, Hunan, China

Site Status

Changsha Central Hospital

Changsha, Hunan, China

Site Status

The Fourth Hospital of Changsha

Changsha, Hunan, China

Site Status

Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status

Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital)

Changsha, Hunan, China

Site Status

Chenzhou First People's Hospital

Chenzhou, Hunan, China

Site Status

Hunan University of Medicine General Hospital

Huaihua, Hunan, China

Site Status

Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital, First Affiliated Hospital of Jishou University School of Medicine

Jishou, Hunan, China

Site Status

The Central Hospital of Shaoyang

Shaoyang, Hunan, China

Site Status

The Central Hospital of Xiangtan, The Affiliated Hospital of Hunan University

Xiangtan, Hunan, China

Site Status

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

Site Status

Yueyang Central Hospital

Yueyang, Hunan, China

Site Status

Zhangjiajie People's Hospital

Zhangjiajie, Hunan, China

Site Status

Zhuzhou Central Hospital

Zhuzhou, Hunan, China

Site Status

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Site Status

Chengdu Fifth Pepole's Hospital

Chengdu, Sichuan, China

Site Status

Xuanwu Hospital Capital Medical University

Beijing, , China

Site Status

Countries

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China

References

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Related Links

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http://rs.yiigle.com/CN112137201709/972019.htm

Chinese Expert Consensus on Monitoring and Treatment of Spontaneous Large Volume Cerebral Hemorrhage

https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFD2007&filename=ZHSJ200706007&uniplatform=NZKPT&v=rxlfgEeP_kUAcTBIbfqYfRPuuVNEEzR8G9G4CfqzrNblOUph8Lyhw1BDdd6rlNpd

Application of noninvasive cerebral electrical impedance measurement on brain edema in patients with intracerebral hemorrhage

https://kns.cnki.net/kcms/detail/detail.aspx?dbcode=CMFD&dbname=CMFD2010&filename=2010015764.nh&uniplatform=NZKPT&v=DZRsncyRWA-kDLE22rWY3SxXwHUbJSHInOPpMy4EgV2S9hjIL3368SpaJS0wzZ_N

A new method of noninvasive brain-edema monitoring in patients with intracranial tumor: cerebral electrical impedance measurement

Other Identifiers

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2018FY100900

Identifier Type: OTHER

Identifier Source: secondary_id

sjnkzhangle

Identifier Type: -

Identifier Source: org_study_id

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