The Impact of Invasive Intracranial Pressure Monitoring Guided Management on the Functional Outcomes of Patients With Supratentorial Large Volume Cerebral Hemorrhage: An Open Label, Randomized, Controlled, Multi-center Trial (BIATICH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 18
- 主要终点
- mRS score on day 90 of treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Elimination criteria：
- •Participants who failed to record any data post-enrollment;
- •Participants who did not receive per-protocol treatment post-enrollment, were discharged within 72 hours, and had their families voluntarily withdraw informed consent;
- •Participants whose invasive intracranial pressure (ICP) monitoring probes shifted and were not promptly reinserted or calibrated, leading to excessive data errors precluding analysis;
- •Participants not receiving the invasive intracranial pressure (ICP) monitoring module according to their assigned group.
结局指标
主要结局
mRS score on day 90 of treatment.
时间窗: 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.
次要结局
- Duration of ICU treatment(90 days)
- GOS-E score(90 days)
- Quality of life score (EQ-5D)(90 days)
- Length of hospitalization(90 days)
- The incidence of serious adverse events(90 days)
- Total mortality(14 days)
- Adverse Events(14 days)
- Severity Adverse Event(14 days)
- The incidence of adverse events That are related to treatment(90 days)
- Categorical shift in Modified Rankin scale(90 days)
- Duration of ICU treatment(90 days)
- GOS-E score(90 days)
- Neurological recovery(14days, 90 days)
- The incidence of serious adverse events(90 days)
- The incidence of adverse events That are related to treatment(90 days)
- Quality of life score (EQ-5D)(90 days)
- Length of hospitalization(90 days)
- Adverse Events(14 days)
- Total mortality(14 days)
- Severity Adverse Event(14 days)