Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial

Not Applicable

Completed

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

• Registration Number: NCT05593380
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Study Start: 2022-11-15
• Status Verified: 2025-02
• Primary Completion: 2025-06-26
• Study Completion: 2025-07-28
• Last Update Submitted: 2025-08-31
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mRS score on day 90 of treatment.	90 days	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.

Secondary Outcome Measures

Name	Time	Method
Categorical shift in Modified Rankin scale	90 days	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).
Duration of ICU treatment	90 days	Time from the start of patient randomization to stable transfer out of the ICU.
GOS-E score	90 days	The difference value of the GOS-E between Day 90，was used to evaluate the functional outcomes after ICH.
Neurological recovery	14days, 90 days	The difference value of the NIHSS between Day 14/Day 90 and the baseline.
The incidence of serious adverse events	90 days	The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
The incidence of adverse events That are related to treatment	90 days	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.
Quality of life score (EQ-5D)	90 days	Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Length of hospitalization	90 days	Length of stay of patients throughout the treatment period since randomization.
Adverse Events	14 days	The percentage of the Adverse Events during the therapy.
Total mortality	14 days	All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
Severity Adverse Event	14 days	The percentage of the Severity Adverse Events within the 14 days of the therapy.

Trial Locations

Locations (17)

The First People's Hospital of Changde City (Changde Hospital, Xiangya School of Medicine, Central South University); 🇨🇳 Changde, Hunan, China

The Fourth Hospital of Changsha; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China

Hunan University of Medicine General Hospital; 🇨🇳 Huaihua, Hunan, China

Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital, First Affiliated Hospital of Jishou University School of Medicine; 🇨🇳 Jishou, Hunan, China

The Central Hospital of Xiangtan, The Affiliated Hospital of Hunan University; 🇨🇳 Xiangtan, Hunan, China

Changsha Central Hospital; 🇨🇳 Changsha, Hunan, China

Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital); 🇨🇳 Changsha, Hunan, China

Chenzhou First People's Hospital; 🇨🇳 Chenzhou, Hunan, China

The Central Hospital of Shaoyang; 🇨🇳 Shaoyang, Hunan, China

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