Cerebral Hemorrhage, HypertensiveBIATICHNCT05593380
Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial
A study testing Parenchymal Intracranial pressure monitor and Treatment based on clinical and imaging observations in people with Cerebral Hemorrhage, Hypertensive and Intracranial Hypertension, run by Xiangya Hospital of Central South University at 17 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Hemorrhage, Hypertensive, Intracranial Hypertension, Monitoring
- What is being tested?
- Parenchymal Intracranial pressure monitor and Treatment based on clinical and imaging observations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 17 sitesChina
- Study dates
- 15 Nov 2022to 28 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Xuanwu Hospital Capital Medical University
Beijing, 1000053
The First People's Hospital of Changde City (Changde Hospital, Xiangya School of Medicine, Central South University)
Changde, Hunan, 410008
Changsha Central Hospital
Changsha, Hunan, 410004
The Fourth Hospital of Changsha
Changsha, Hunan, 410008
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital)
Changsha, Hunan
Chengdu Fifth Pepole's Hospital
Chengdu, Sichuan
Chenzhou First People's Hospital
Chenzhou, Hunan, 410008
Hunan University of Medicine General Hospital
Huaihua, Hunan, 410008
Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital, First Affiliated Hospital of Jishou University School of Medicine
Jishou, Hunan, 416000
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
The Central Hospital of Shaoyang
Shaoyang, Hunan, 410008
The Central Hospital of Xiangtan, The Affiliated Hospital of Hunan University
Xiangtan, Hunan, 410008
The Central Hospital of Yongzhou
Yongzhou, Hunan, 410008
Yueyang Central Hospital
Yueyang, Hunan, 414000
Zhangjiajie People's Hospital
Zhangjiajie, Hunan, 427000
Zhuzhou Central Hospital
Zhuzhou, Hunan, 410008
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Cerebral Hemorrhage, Hypertensive, Intracranial Hypertension, Monitoring, Critical Care, Treatment Outcome, Invasive Intracranial Pressure Monitoring
- Being tested
- Parenchymal Intracranial pressure monitor, Treatment based on clinical and imaging observations
- Keywords
- Spontaneous cerebral hemorrhage, Brain Edema, Intracranial Hypertension, Massive intracerebral hemorrhage, Treatment Outcome, invasive intracranial pressure monitoring, Large-volume cerebral hemorrhage
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive, Intracranial Hypertension, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenchymal Intracranial pressure monitorDevice
Also called Integra Life Sciences Camino Intracranial Monitor
Treatment based on readings from Parenchymal intracranial pressure monitor.
Treatment based on clinical and imaging observationsOther
Treatment based on clinical and imaging observations.
| Study group | Role | What they receive |
|---|---|---|
| ICP monitoring | Experimental | Intracranial pressure monitoring equipment enables continuous dynamic monitoring of changes in intracranial pressure values. This technology reflects sudden shifts in intracranial pressure resulting from hemorrhage and other cranial conditions, allowing for timely adjustments in the intensity of cerebral therapeutic interventions. Receives: Device: Parenchymal Intracranial pressure monitor |
| imaging-clinical examination (ICE) | Other | According to routine head CT imaging examinations, dynamic observations of changes in the patient's condition should be conducted. This involves closely monitoring clinical consciousness, pupil response, limb activity, and other clinical manifestations. Adjustments to the intensity of cerebral intervention should be made based on the clinical reflections of these dynamic changes. Receives: Other: Treatment based on clinical and imaging observations |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score on day 90 of treatment.
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.
Measured: 90 days
Secondary outcomes (13)
Categorical shift in Modified Rankin scale
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).
Measured: 90 days
Neurological recovery
The difference value of the NIHSS between Day 14/Day 90 and the baseline.
Measured: 14days, 90 days
Duration of ICU treatment
Time from the start of patient randomization to stable transfer out of the ICU.
Measured: 90 days
GOS-E score
The difference value of the GOS-E between Day 90，was used to evaluate the functional outcomes after ICH.
Measured: 90 days
Quality of life score (EQ-5D)
Generic health status evaluated by EQ-5D questionnaire at the end of the therapy.
Measured: 90 days
Length of hospitalization
Length of stay of patients throughout the treatment period since randomization.
Measured: 90 days
The incidence of serious adverse events
The percentage of the Severity Adverse Events within the 14 days/90 days of the therapy.
Measured: 90 days
Total mortality
All deaths reported post-randomization will be recorded and adjudicated
Measured: 90 days
Adverse Events
The percentage of the Adverse Events during the therapy.
Measured: 90 days
Severity Adverse Event
The percentage of the Severity Adverse Events within the 14 days of the therapy.
Measured: 14 days
Total mortality
All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.
Measured: 14 days
Adverse Events
The percentage of the Adverse Events during the therapy.
Measured: 14 days
The incidence of adverse events That are related to treatment
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start15 Nov 2022
- Primary completion26 Jun 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Cerebral Hemorrhage, HypertensiveStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Le, PhD, Principal investigator, Department of Neurology，Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593380
- Sponsor's protocol ID
- sjnkzhangle
- Other IDs
- 2018FY100900
- Acronym
- BIATICH
- Status last verified
- Feb 2025
- First submitted
- 20 Oct 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.
PubMed 28919116Bao YH, Liang YM, Gao GY, Pan YH, Luo QZ, Jiang JY. Bilateral decompressive craniectomy for patients with malignant diffuse brain swelling after severe traumatic brain injury: a 37-case study. J Neurotrauma. 2010 Feb;27(2):341-7. doi: 10.1089/neu.2009.1040.
PubMed 19715392Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
PubMed 27654000Chesnut RM, Temkin N, Carney N, Dikmen S, Rondina C, Videtta W, Petroni G, Lujan S, Pridgeon J, Barber J, Machamer J, Chaddock K, Celix JM, Cherner M, Hendrix T; Global Neurotrauma Research Group. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med. 2012 Dec 27;367(26):2471-81. doi: 10.1056/NEJMoa1207363. Epub 2012 Dec 12.
PubMed 23234472Raj R, Bendel S, Reinikainen M, Hoppu S, Laitio R, Ala-Kokko T, Curtze S, Skrifvars MB. Costs, outcome and cost-effectiveness of neurocritical care: a multi-center observational study. Crit Care. 2018 Sep 20;22(1):225. doi: 10.1186/s13054-018-2151-5.
PubMed 30236140Kumar G, Kalita J, Misra UK. Raised intracranial pressure in acute viral encephalitis. Clin Neurol Neurosurg. 2009 Jun;111(5):399-406. doi: 10.1016/j.clineuro.2009.03.004. Epub 2009 Apr 15.
PubMed 19372001Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126.
PubMed 15145991Treggiari MM, Schutz N, Yanez ND, Romand JA. Role of intracranial pressure values and patterns in predicting outcome in traumatic brain injury: a systematic review. Neurocrit Care. 2007;6(2):104-12. doi: 10.1007/s12028-007-0012-1.
PubMed 17522793Helbok R, Olson DM, Le Roux PD, Vespa P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure and cerebral perfusion pressure monitoring in non-TBI patients: special considerations. Neurocrit Care. 2014 Dec;21 Suppl 2:S85-94. doi: 10.1007/s12028-014-0040-6.
PubMed 25208677Simma B, Burger R, Falk M, Sacher P, Fanconi S. A prospective, randomized, and controlled study of fluid management in children with severe head injury: lactated Ringer's solution versus hypertonic saline. Crit Care Med. 1998 Jul;26(7):1265-70. doi: 10.1097/00003246-199807000-00032.
PubMed 9671379O'Sullivan MG, Statham PF, Jones PA, Miller JD, Dearden NM, Piper IR, Anderson SI, Housley A, Andrews PJ, Midgley S, et al. Role of intracranial pressure monitoring in severely head-injured patients without signs of intracranial hypertension on initial computerized tomography. J Neurosurg. 1994 Jan;80(1):46-50. doi: 10.3171/jns.1994.80.1.0046.
PubMed 8271021Hiler M, Czosnyka M, Hutchinson P, Balestreri M, Smielewski P, Matta B, Pickard JD. Predictive value of initial computerized tomography scan, intracranial pressure, and state of autoregulation in patients with traumatic brain injury. J Neurosurg. 2006 May;104(5):731-7. doi: 10.3171/jns.2006.104.5.731.
PubMed 16703877Ropper AH. Management of raised intracranial pressure and hyperosmolar therapy. Pract Neurol. 2014 Jun;14(3):152-8. doi: 10.1136/practneurol-2014-000811. Epub 2014 Jan 30.
PubMed 24481284Bales JW, Bonow RH, Buckley RT, Barber J, Temkin N, Chesnut RM. Primary External Ventricular Drainage Catheter Versus Intraparenchymal ICP Monitoring: Outcome Analysis. Neurocrit Care. 2019 Aug;31(1):11-21. doi: 10.1007/s12028-019-00712-9.
PubMed 31037639Aiolfi A, Khor D, Cho J, Benjamin E, Inaba K, Demetriades D. Intracranial pressure monitoring in severe blunt head trauma: does the type of monitoring device matter? J Neurosurg. 2018 Mar;128(3):828-833. doi: 10.3171/2016.11.JNS162198. Epub 2017 May 26.
PubMed 28548592
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05593380
- Acronym / sponsor ID
- BIATICH / sjnkzhangle
- Conditions
- Cerebral Hemorrhage, Hypertensive, Intracranial Hypertension, Monitoring, Critical Care, Treatment Outcome, Invasive Intracranial Pressure Monitoring
- Keywords
- Spontaneous cerebral hemorrhage, Brain Edema, Intracranial Hypertension, Massive intracerebral hemorrhage, Treatment Outcome, invasive intracranial pressure monitoring, Large-volume cerebral hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP monitoring | Experimental | Device: Parenchymal Intracranial pressure monitorIntracranial pressure monitoring equipment enables continuous dynamic monitoring of changes in intracranial pressure values. This technology reflects sudden shifts in intracranial pressure resulting from hemorrhage and other cranial conditions, allowing for timely adjustments in the intensity of cerebral therapeutic interventions. |
| imaging-clinical examination (ICE) | Other | Other: Treatment based on clinical and imaging observationsAccording to routine head CT imaging examinations, dynamic observations of changes in the patient's condition should be conducted. This involves closely monitoring clinical consciousness, pupil response, limb activity, and other clinical manifestations. Adjustments to the intensity of cerebral intervention should be made based on the clinical reflections of these dynamic changes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenchymal Intracranial pressure monitorAlso: Integra Life Sciences Camino Intracranial MonitorTreatment based on readings from Parenchymal intracranial pressure monitor. | Device | ICP monitoring |
| Treatment based on clinical and imaging observationsTreatment based on clinical and imaging observations. | Other | imaging-clinical examination (ICE) |
Primary outcome
mRS score on day 90 of treatment.
Time frame: 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.
13 secondary outcomes
Categorical shift in Modified Rankin scale
Time frame: 90 days
Neurological recovery
Time frame: 14days, 90 days
Duration of ICU treatment
Time frame: 90 days
GOS-E score
Time frame: 90 days
Quality of life score (EQ-5D)
Time frame: 90 days
Length of hospitalization
Time frame: 90 days
The incidence of serious adverse events
Time frame: 90 days
Total mortality
Time frame: 90 days
Adverse Events
Time frame: 90 days
Severity Adverse Event
Time frame: 14 days
Total mortality
Time frame: 14 days
Adverse Events
Time frame: 14 days
The incidence of adverse events That are related to treatment
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 28919116GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9.
- Results publication: PubMed 19715392Bao YH, Liang YM, Gao GY, Pan YH, Luo QZ, Jiang JY. Bilateral decompressive craniectomy for patients with malignant diffuse brain swelling after severe traumatic brain injury: a 37-case study. J Neurotrauma. 2010 Feb;27(2):341-7. doi: 10.1089/neu.2009.1040.
- Results publication: PubMed 27654000Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
- Results publication: PubMed 23234472Chesnut RM, Temkin N, Carney N, Dikmen S, Rondina C, Videtta W, Petroni G, Lujan S, Pridgeon J, Barber J, Machamer J, Chaddock K, Celix JM, Cherner M, Hendrix T; Global Neurotrauma Research Group. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med. 2012 Dec 27;367(26):2471-81. doi: 10.1056/NEJMoa1207363. Epub 2012 Dec 12.
- Results publication: PubMed 30236140Raj R, Bendel S, Reinikainen M, Hoppu S, Laitio R, Ala-Kokko T, Curtze S, Skrifvars MB. Costs, outcome and cost-effectiveness of neurocritical care: a multi-center observational study. Crit Care. 2018 Sep 20;22(1):225. doi: 10.1186/s13054-018-2151-5.
- Results publication: PubMed 19372001Kumar G, Kalita J, Misra UK. Raised intracranial pressure in acute viral encephalitis. Clin Neurol Neurosurg. 2009 Jun;111(5):399-406. doi: 10.1016/j.clineuro.2009.03.004. Epub 2009 Apr 15.
- Results publication: PubMed 15145991Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126.
- Results publication: PubMed 17522793Treggiari MM, Schutz N, Yanez ND, Romand JA. Role of intracranial pressure values and patterns in predicting outcome in traumatic brain injury: a systematic review. Neurocrit Care. 2007;6(2):104-12. doi: 10.1007/s12028-007-0012-1.
- Results publication: PubMed 25208677Helbok R, Olson DM, Le Roux PD, Vespa P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure and cerebral perfusion pressure monitoring in non-TBI patients: special considerations. Neurocrit Care. 2014 Dec;21 Suppl 2:S85-94. doi: 10.1007/s12028-014-0040-6.
- Results publication: PubMed 9671379Simma B, Burger R, Falk M, Sacher P, Fanconi S. A prospective, randomized, and controlled study of fluid management in children with severe head injury: lactated Ringer's solution versus hypertonic saline. Crit Care Med. 1998 Jul;26(7):1265-70. doi: 10.1097/00003246-199807000-00032.
- Results publication: PubMed 8271021O'Sullivan MG, Statham PF, Jones PA, Miller JD, Dearden NM, Piper IR, Anderson SI, Housley A, Andrews PJ, Midgley S, et al. Role of intracranial pressure monitoring in severely head-injured patients without signs of intracranial hypertension on initial computerized tomography. J Neurosurg. 1994 Jan;80(1):46-50. doi: 10.3171/jns.1994.80.1.0046.
- Results publication: PubMed 16703877Hiler M, Czosnyka M, Hutchinson P, Balestreri M, Smielewski P, Matta B, Pickard JD. Predictive value of initial computerized tomography scan, intracranial pressure, and state of autoregulation in patients with traumatic brain injury. J Neurosurg. 2006 May;104(5):731-7. doi: 10.3171/jns.2006.104.5.731.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Le, PhD principal investigator
Department of Neurology，Xiangya Hospital, Central South University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenchymal Intracranial pressure monitor and Treatment based on clinical and imaging observations in people with Cerebral Hemorrhage, Hypertensive and Intracranial Hypertension, run by Xiangya Hospital of Central South University at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS score on day 90 of treatment. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05593380, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.