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Search / Trial NCT05593380

The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH

Launched by XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Oct 20, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Spontaneous Cerebral Hemorrhage Brain Edema Intracranial Hypertension Non Invasive Intracranial Pressure Monitoring Massive Intracerebral Hemorrhage Treatment Outcome Invasive Intracranial Pressure Monitoring Large Volume Cerebral Hemorrhage

ClinConnect Summary

This clinical trial is studying how a new method of monitoring brain swelling (or edema) can help improve outcomes for patients with large-volume spontaneous cerebral hemorrhages, which are bleeding events in the brain that can lead to serious complications. Researchers are particularly interested in how this non-invasive monitoring, using a technology called bioelectrical impedance, can help identify patients at risk for worsening conditions and guide their treatment. The goal is to find better ways to manage these patients and ultimately improve their chances of recovery.

To participate in this study, individuals need to be between 18 and 80 years old and have been diagnosed with a large-volume cerebral hemorrhage. They must also be admitted to the hospital within 48 hours of their symptoms starting. Participants will receive close monitoring and care while the effects of this new monitoring system are evaluated. This trial is important because it aims to provide valuable information that could lead to better treatment options for patients suffering from this serious condition.

Gender

ALL

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.

About Xiangya Hospital Of Central South University

Xiangya Hospital of Central South University is a leading academic medical institution located in Changsha, China, renowned for its commitment to advancing healthcare through innovative clinical research and patient-centered care. As a key affiliate of Central South University, the hospital integrates clinical practice with medical education and research, fostering an environment that promotes the development of cutting-edge therapies and treatments. With a diverse array of specialized departments and a dedicated team of healthcare professionals, Xiangya Hospital actively participates in clinical trials aimed at enhancing medical knowledge and improving patient outcomes, contributing significantly to the global medical community.

Locations

Nanchang, Jiangxi, China

Beijing, , China

Yueyang, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Changde, Hunan, China

Changsha, Hunan, China

Changsha, Hunan, China

Chenzhou, Hunan, China

Huaihua, Hunan, China

Shaoyang, Hunan, China

Xiangtan, Hunan, China

Yongzhou, Hunan, China

Zhuzhou, Hunan, China

Chengdu, Sichuan, China

Patients applied

0 patients applied

Trial Officials

Zhang Le, PhD

Principal Investigator

Department of Neurology,XiangYa School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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