Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial

NCT05593380 | Completed DMC

• 2 other identifiers: sjnkzhangle2018FY100900
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 17

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. 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.

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; Massive intracerebral hemorrhage; Treatment Outcome; invasive intracranial pressure monitoring; Large-volume cerebral hemorrhage

Outcome Measures

Primary Outcomes (1)

• mRS score on day 90 of treatment.

  The differences between the two groups were evaluated using the modified Rankin Scale (mRS) at 90 days post-treatment. Additionally, the proportion of patients achieving functional independence, defined as an mRS score of 0-3, was calculated.

  90 days

Secondary Outcomes (13)

• Categorical shift in Modified Rankin scale

  90 days

• Neurological recovery

  14days, 90 days

• Duration of ICU treatment

  90 days

• GOS-E score

  90 days

• Quality of life score (EQ-5D)

  90 days

Study Arms (2)

ICP monitoring

EXPERIMENTAL

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.

Device: Parenchymal Intracranial pressure monitor

imaging-clinical examination (ICE)

OTHER

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.

Other: Treatment based on clinical and imaging observations

Interventions

Parenchymal Intracranial pressure monitor DEVICE

Treatment based on readings from Parenchymal intracranial pressure monitor.

Also known as: Integra Life Sciences Camino Intracranial Monitor

ICP monitoring

Treatment based on clinical and imaging observations OTHER

Treatment based on clinical and imaging observations.

imaging-clinical examination (ICE)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Participants were enrolled within 48 hours of symptom onset.
• The family signed the informed consent.

You may not qualify if:

• 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.
• Individuals unable to complete the follow-up phase of this trial due to psychiatric, cognitive, or emotional conditions;
• Family members decline to provide informed consent.
• Exit criteria:
• Acute onset of other life-threatening illnesses identified as the primary cause of mortality;
• Participants who voluntarily withdraw from the study before completion;
• Participants deemed unsuitable for the trial's monitoring protocol post-enrollment;
• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (17)

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

Changde, Hunan, 410008, China

Location

Changsha Central Hospital

Changsha, Hunan, 410004, China

Location

The Fourth Hospital of Changsha

Changsha, Hunan, 410008, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital)

Changsha, Hunan, China

Location

Chenzhou First People's Hospital

Chenzhou, Hunan, 410008, China

Location

Hunan University of Medicine General Hospital

Huaihua, Hunan, 410008, China

Location

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

Jishou, Hunan, 416000, China

Location

The Central Hospital of Shaoyang

Shaoyang, Hunan, 410008, China

Location

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

Xiangtan, Hunan, 410008, China

Location

The Central Hospital of Yongzhou

Yongzhou, Hunan, 410008, China

Location

Yueyang Central Hospital

Yueyang, Hunan, 414000, China

Location

Zhangjiajie People's Hospital

Zhangjiajie, Hunan, 427000, China

Location

Zhuzhou Central Hospital

Zhuzhou, Hunan, 410008, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

Location

Chengdu Fifth Pepole's Hospital

Chengdu, Sichuan, China

Location

Xuanwu Hospital Capital Medical University

Beijing, 1000053, China

Location

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Related Links

• Chinese Expert Consensus on Monitoring and Treatment of Spontaneous Large Volume Cerebral Hemorrhage
• An applied research on non-invasive and dynamic monitor of cerebral edema in patients after craniotomy
• Trunk subdivision bioelectrical impedance analysis of body composition
• Disturbance method of electric current field and its application in impedance imaging
• Noninvasive monitoring of hypertensive intracerebral hemorrhage and perihematomal tissue edema
• Application of noninvasive cerebral electrical impedance measurement on brain edema in patients with intracerebral hemorrhage
• A new method of noninvasive brain-edema monitoring in patients with intracranial tumor: cerebral electrical impedance measurement
• An applied research on non-invasive and dynamic monitor of cerebral edema in patients after craniotomy
• Application of continuous intracranial pressure monitoring in hypertensive cerebral hemorrhge

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive; Intracranial Hypertension; Brain Edema

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhang Le, PhD

  Department of Neurology，Xiangya Hospital, Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: November 15, 2022
• Primary Completion: June 26, 2025
• Study Completion: July 28, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)