Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial

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

Interventions

DEVICE

Parenchymal Intracranial pressure monitor

Treatment based on readings from Parenchymal intracranial pressure monitor.

OTHER

Treatment based on clinical and imaging observations

Treatment based on clinical and imaging observations.

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  lead OTHER

Principal Investigators

• Zhang Le, PhD · Department of Neurology，Xiangya Hospital, Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-15

Primary Completion

2025-06-26

Completion

2025-07-28

Countries

• China

Study Locations