Monitoring brain edema to improve outcomes in patients with large cerebral hemorrhage

The Effect of BIA Monitoring of Brainedemaontheneurological Prognosis of Supratentorial Massive Intracerebral Hemorrhage - A Randomized, Contrast，Multi-center Trial

This study is testing if continuous monitoring of pressure in the brain can help improve recovery and lower the risk of death for patients with large brain bleeds after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Locations: 16 sites (Changde, Hunan and 15 other locations)
• Trial ID: NCT05593380 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of continuous ambulatory monitoring of intracranial pressure on the neurological prognosis of patients with large-volume supratentorial cerebral hemorrhage. It aims to determine if this non-invasive monitoring can guide therapeutic interventions and reduce early mortality rates within 14 days post-surgery. The study is a prospective, open-label, randomized, controlled trial involving approximately 190 patients across multiple clinical institutions in China. Eligible participants are those diagnosed with significant supratentorial hemorrhage within 48 hours of symptom onset, and informed consent is obtained from their families.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 diagnosed with supratentorial spontaneous intracerebral hemorrhage of at least 30 mL.

Not a fit: Patients with traumatic cerebral hemorrhage or other specific etiologies of secondary cerebral hemorrhage will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the prognosis and reduce mortality rates for patients suffering from large-volume cerebral hemorrhage.

How similar studies have performed: While there is ongoing research in intracranial pressure monitoring, this specific approach to large-volume cerebral hemorrhage is relatively novel and has not been extensively tested.

Eligibility criteria

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. Admission to study hospital within 48 hours of the disease.
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.

Where this trial is running

Changde, Hunan and 15 other locations

• The First People's Hospital of Changde — Changde, Hunan, China (Recruiting)
• Changsha Fourth Hospital — Changsha, Hunan, China (Recruiting)
• XiangYa School of Medicine — Changsha, Hunan, China (Recruiting)
• Zhangjiajie People's Hospital — Changsha, Hunan, China (Recruiting)
• Changsha Central Hospital — Changsha, Hunan, China (Recruiting)
• Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital) — Changsha, Hunan, China (Recruiting)
• Chenzhou First People's Hospital — Chenzhou, Hunan, China (Recruiting)
• Hunan University of Medicine Hospital — Huaihua, Hunan, China (Recruiting)
• The Central Hospital of Shaoyang — Shaoyang, Hunan, China (Recruiting)
• Xiangtan Central Hospital — Xiangtan, Hunan, China (Recruiting)
• The Central Hospital of Yongzhou — Yongzhou, Hunan, China (Recruiting)
• Yueyang Central Hospital — Yueyang, Hunan, China (Recruiting)
• Zhuzhou Central Hospital — Zhuzhou, Hunan, China (Recruiting)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (Recruiting)
• Chengdu Fifth Pepole's Hospital — Chengdu, Sichuan, China (Recruiting)
• Xuanwu Hospital Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Zhang Le, PhD — Department of Neurology，XiangYa School of Medicine
• Study coordinator: Zhang Le, PhD

Conditions Cerebral Hemorrhage, Hypertensive; Intracranial Hypertension; Monitoring; Critical Care; Treatment Outcome; Invasive Intracranial Pressure Monitoring; Large-volume Cerebral Hemorrhage; Spontaneous cerebral hemorrhage