Bleeding Intracerebral Hemorrhage With Early Invasive Intracranial Pressure Monitoring Trial
NCT ID: NCT05593380
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
193 participants
INTERVENTIONAL
2022-11-15
2025-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ICP monitoring
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.
Parenchymal Intracranial pressure monitor
Treatment based on readings from Parenchymal intracranial pressure monitor.
imaging-clinical examination (ICE)
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.
Treatment based on clinical and imaging observations
Treatment based on clinical and imaging observations.
Interventions
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Parenchymal Intracranial pressure monitor
Treatment based on readings from Parenchymal intracranial pressure monitor.
Treatment based on clinical and imaging observations
Treatment based on clinical and imaging observations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Participants were enrolled within 48 hours of symptom onset.
5. The family signed the informed consent.
Exclusion Criteria
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.
9. Individuals unable to complete the follow-up phase of this trial due to psychiatric, cognitive, or emotional conditions;
10. Family members decline to provide informed consent.
Exit criteria:
1. Acute onset of other life-threatening illnesses identified as the primary cause of mortality;
2. Participants who voluntarily withdraw from the study before completion;
3. Participants deemed unsuitable for the trial's monitoring protocol post-enrollment;
4. 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:
1. Participants who failed to record any data post-enrollment;
2. Participants who did not receive per-protocol treatment post-enrollment, were discharged within 72 hours, and had their families voluntarily withdraw informed consent;
3. Participants whose invasive intracranial pressure (ICP) monitoring probes shifted and were not promptly reinserted or calibrated, leading to excessive data errors precluding analysis;
4. Participants not receiving the invasive intracranial pressure (ICP) monitoring module according to their assigned group.
18 Years
80 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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Zhang Le, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology,Xiangya Hospital, Central South University
Locations
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The First People's Hospital of Changde City (Changde Hospital, Xiangya School of Medicine, Central South University)
Changde, Hunan, China
Changsha Central Hospital
Changsha, Hunan, China
The Fourth Hospital of Changsha
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital)
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Hunan University of Medicine General Hospital
Huaihua, Hunan, China
Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital, First Affiliated Hospital of Jishou University School of Medicine
Jishou, Hunan, China
The Central Hospital of Shaoyang
Shaoyang, Hunan, China
The Central Hospital of Xiangtan, The Affiliated Hospital of Hunan University
Xiangtan, Hunan, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
Zhangjiajie People's Hospital
Zhangjiajie, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Chengdu Fifth Pepole's Hospital
Chengdu, Sichuan, China
Xuanwu Hospital Capital Medical University
Beijing, , China
Countries
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References
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Related Links
Access external resources that provide additional context or updates about the study.
Chinese Expert Consensus on Monitoring and Treatment of Spontaneous Large Volume Cerebral Hemorrhage
An applied research on non-invasive and dynamic monitor of cerebral edema in patients after craniotomy
Trunk subdivision bioelectrical impedance analysis of body composition
Disturbance method of electric current field and its application in impedance imaging
Noninvasive monitoring of hypertensive intracerebral hemorrhage and perihematomal tissue edema
Application of noninvasive cerebral electrical impedance measurement on brain edema in patients with intracerebral hemorrhage
A new method of noninvasive brain-edema monitoring in patients with intracranial tumor: cerebral electrical impedance measurement
An applied research on non-invasive and dynamic monitor of cerebral edema in patients after craniotomy
Application of continuous intracranial pressure monitoring in hypertensive cerebral hemorrhge
Other Identifiers
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2018FY100900
Identifier Type: OTHER
Identifier Source: secondary_id
sjnkzhangle
Identifier Type: -
Identifier Source: org_study_id
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