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Bladder thermometer may boost brain bleed recovery

NCT ID NCT07302009

Disease control Sponsor: Yanyan Gong Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a special bladder catheter that continuously measures body temperature can help guide treatment and improve recovery in people with severe brain bleeding. About 318 participants will be randomly assigned to either continuous bladder temperature monitoring or standard armpit temperature checks. The main goal is to see if more people achieve a good functional outcome (able to live independently) 180 days later.

What this could mean

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

Active substance
Bladder temperature monitoring device
What this could lead to
If successful, this could show that continuous bladder temperature monitoring helps guide treatment and improves functional recovery after severe brain bleeding.
What could go wrong
This is a relatively early-stage trial (Phase NA) with 318 participants. The intervention is a monitoring device, not a drug, so the potential impact is limited to better temperature management, not a cure. Risks include infections or complications from the catheter.

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

About 318 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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 85 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. Neurocritical care patients: Study subjects are patients with first-time spontaneous intracerebral hemorrhage. 2. Age ≥ 18 years and ≤ 85 years. 3. Glasgow Coma Scale (GCS) score ≤ 8 at ICU admission. 4. For supratentorial ICH: Hematoma volume \< 60 mL. For subarachnoid hemorrhage (SAH): Modified Fisher grade ≥ 2, and the aneurysm has been treated with endovascular intervention. 5. Pre-morbid modified Rankin Scale (mRS) score of 0 or 1. 6. Signed informed consent provided by a legally authorized representative. Exclusion Criteria: 1. Fever (≥38.0°C) that lasted over 1 hour or occurred more than once prior to enrollment. 2. Pre-existing neurological, psychiatric, or other comorbidities that may compromise the assessment of neurological or functional outcomes. 3. Underlying conditions with a life expectancy of less than 6 months, estimated prior to onset. 4. Severe injury indicative of poor prognosis: brain death, receiving palliative care only, or irreversible brain injury. 5. Pregnancy. 6. Unilateral or bilateral pupillary dilation. 7. Currently participating in other investigational/interventional clinical trials (involving medical devices or drugs). 8. Subjects deemed ineligible for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage subarachnoid hemorrhage

As listed by the trial registrant

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

Intracerebral hemorrhage Targeted temperature management

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

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