Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial

Overview

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.

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.