An interventional study of Parenchymal Intracranial pressure monitor and Treatment based on clinical and imaging observations in Cerebral Hemorrhage, Hypertensive, Intracranial Hypertension and Monitoring, sponsored by Xiangya Hospital of Central South University. Completed at 17 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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.
23 studies on the registry are indexed under Intracranial Hemorrhage, Hypertensive; 8 are open to participants now.
This study's enrollment of 193 is below the median of 306 across 17 interventional studies indexed under Intracranial Hemorrhage, Hypertensive.
Browse Intracranial Hemorrhage, Hypertensive studies →Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.
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Exit criteria:
Elimination criteria：
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Treatment based on readings from Parenchymal intracranial pressure monitor.
Also known as: Integra Life Sciences Camino Intracranial Monitor
Treatment based on clinical and imaging observations.
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.
Time frame: 90 days
Categorical shift in Modified Rankin scale
The modified Rankin Scale (mRS) is utilized to assess functional outcomes following intracerebral hemorrhage (ICH), with scores ranging from 0 (no symptoms) to 6 (death). The study compared mRS scores between the two groups at 14 and 90 days post-treatment, categorized as favorable (0-3) and unfavorable (4-6) outcomes. Additionally, the study investigated other mRS classifications, including good prognosis (0-2), moderate prognosis (3-4), and poor prognosis (≥5).
Time frame: 90 days
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Time frame: 14days, 90 days
Duration of ICU treatment
Time from the start of patient randomization to stable transfer out of the ICU.
Time frame: 90 days
GOS-E score
The difference value of the GOS-E between Day 90，was used to evaluate the functional outcomes after ICH.
Time frame: 90 days
Quality of life score (EQ-5D)
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Time frame: 90 days
Length of hospitalization
Length of stay of patients throughout the treatment period since randomization.
Time frame: 90 days
The incidence of serious adverse events
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
Time frame: 90 days
Total mortality
All deaths reported post-randomization will be recorded and adjudicated
Time frame: 90 days
Adverse Events
The percentage of the Adverse Events during the therapy.
Time frame: 90 days
Severity Adverse Event
The percentage of the Severity Adverse Events within the 14 days of the therapy.
Time frame: 14 days
Total mortality
All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
Time frame: 14 days
Adverse Events
The percentage of the Adverse Events during the therapy.
Time frame: 14 days
The incidence of adverse events That are related to treatment
The incidence of complications, including intracranial infections, probe displacement, recurrent intracranial hemorrhage, and skin infections, was assessed following the random grouping of patients undergoing invasive intracranial pressure (ICP) monitoring.
Time frame: 90 days
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Intracranial Hemorrhage, Hypertensive →
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