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Brain pressure monitor could boost recovery after major bleed

NCT ID NCT05593380

Disease control Sponsor: Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether using a device to measure pressure inside the skull helps doctors treat people with a large brain bleed. 193 patients were randomly assigned to get either standard care or care guided by the pressure monitor. The goal was to see if the monitor helped more patients recover with less disability after 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intracranial pressure monitor (device)
What this could lead to
If successful, this could show that using a brain pressure monitor helps doctors make better treatment decisions, improving recovery and reducing disability after a large brain bleed.
What could go wrong
This is a completed trial with 193 patients, but it's still a relatively small study. The results may not apply to all patients, and the device itself carries a small risk of infection or bleeding during placement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

193 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Participants were enrolled within 48 hours of symptom onset. 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. 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.

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Conditions

The condition(s) this trial relates to.

brain edema intracerebral hemorrhage Intracranial Hemorrhage, Hypertensive intracranial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral hemorrhage, hypertensive Critical care Intracranial hypertension Invasive intracranial pressure monitoring Large-volume cerebral hemorrhage Monitoring Treatment outcome

Contacts and locations

Locations

  • Changsha Central Hospital

    Changsha, Hunan, 410004, China

  • Changsha Hospital of Traditional Chinese Medicine (Changsha Eighth Hospital)

    Changsha, Hunan, China

  • Chengdu Fifth Pepole's Hospital

    Chengdu, Sichuan, China

  • Chenzhou First People's Hospital

    Chenzhou, Hunan, 410008, China

  • Hunan University of Medicine General Hospital

    Huaihua, Hunan, 410008, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006, China

  • The Central Hospital of Shaoyang

    Shaoyang, Hunan, 410008, China

  • The Central Hospital of Xiangtan, The Affiliated Hospital of Hunan University

    Xiangtan, Hunan, 410008, China

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan, 410008, China

  • The First People's Hospital of Changde City (Changde Hospital, Xiangya School of Medicine, Central South University)

    Changde, Hunan, 410008, China

  • The Fourth Hospital of Changsha

    Changsha, Hunan, 410008, China

  • Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital, First Affiliated Hospital of Jishou University School of Medicine

    Jishou, Hunan, 416000, China

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008, China

  • Xuanwu Hospital Capital Medical University

    Beijing, 1000053, China

  • Yueyang Central Hospital

    Yueyang, Hunan, 414000, China

  • Zhangjiajie People's Hospital

    Zhangjiajie, Hunan, 427000, China

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 410008, China

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