NCT05593380Completed
Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial
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)
Source: ClinicalTrials.gov · Last updated 8 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 193 (actual)
- First submitted
- 20 Oct 2022
- Start date
- 15 Nov 2022
- Primary completion date
- 26 Jun 2025
- Lead sponsor
- Xiangya Hospital of Central South University
- Diseases
- High blood pressure
- NCT number
- NCT05593380
What you commit to
- Study type: Interventional
- Participants enrolled: 193
- From 15 Nov 2022 to the primary completion date, 26 Jun 2025
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants not receiving the invasive intracranial pressure (ICP) monitoring module according to their assigned group.
Other illness
- 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.)
- Individuals unable to complete the follow-up phase of this trial due to psychiatric, cognitive, or emotional conditions;
- Acute onset of other life-threatening illnesses identified as the primary cause of mortality;
Lab values
- 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.)
Other
- 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 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.
- Family members decline to provide informed consent.
- Exit criteria:
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First People's Hospital of Changde City (Changde Hospital, Xiangya School of Medicine, Central South University) Coordinator of this site? Confirm its status | Changde | China | Unknown status |
| Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital) Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Fourth Hospital of Changsha Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Changsha Central Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chengdu Fifth Pepole's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chenzhou First People's Hospital Coordinator of this site? Confirm its status | Chenzhou | China | Unknown status |
| Hunan University of Medicine General Hospital Coordinator of this site? Confirm its status | Huaihua | China | Unknown status |
| Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital, First Affiliated Hospital of Jishou University School of Medicine Coordinator of this site? Confirm its status | Jishou | China | Unknown status |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Central Hospital of Shaoyang Coordinator of this site? Confirm its status | Shaoyang | China | Unknown status |
| The Central Hospital of Xiangtan, The Affiliated Hospital of Hunan University Coordinator of this site? Confirm its status | Xiangtan | China | Unknown status |
| The Central Hospital of Yongzhou Coordinator of this site? Confirm its status | Yongzhou | China | Unknown status |
| Yueyang Central Hospital Coordinator of this site? Confirm its status | Yueyang | China | Unknown status |
| Zhangjiajie People's Hospital Coordinator of this site? Confirm its status | Zhangjiajie | China | Unknown status |
| Zhuzhou Central Hospital Coordinator of this site? Confirm its status | Zhuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.