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Intracerebral HemorrhageBTTM-ICHNCT07302009

Targeted Temperature Management Via Bladder Monitoring in ICH

A study testing Bladder Temperature Monitoring and Standard Temperature Monitoring Group in people with Intracerebral Hemorrhage and Targeted Temperature Management, run by Yanyan Gong at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn whether a bladder temperature monitoring-guided targeted temperature management (TTM) strategy improves functional recovery in patients with severe intracerebral hemorrhage, compared to conventional temperature monitoring. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Bladder Temperature Monitoring and Standard Temperature Monitoring Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
1 siteChina
Study dates
15 Mar 2026to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Neurocritical care patients: Study subjects are patients with first-time spontaneous intracerebral hemorrhage.
  • Age ≥ 18 years and ≤ 85 years.
  • Glasgow Coma Scale (GCS) score ≤ 8 at ICU admission.
  • For supratentorial ICH: Hematoma volume < 60 mL. For subarachnoid hemorrhage (SAH): Modified Fisher grade ≥ 2, and the aneurysm has been treated with endovascular intervention.
  • Pre-morbid modified Rankin Scale (mRS) score of 0 or 1.
  • Signed informed consent provided by a legally authorized representative.

Who cannot join

  • Fever (≥38.0°C) that lasted over 1 hour or occurred more than once prior to enrollment.
  • Pre-existing neurological, psychiatric, or other comorbidities that may compromise the assessment of neurological or functional outcomes.
  • Underlying conditions with a life expectancy of less than 6 months, estimated prior to onset.
  • Severe injury indicative of poor prognosis: brain death, receiving palliative care only, or irreversible brain injury.
  • Pregnancy.
  • Unilateral or bilateral pupillary dilation.
  • Currently participating in other investigational/interventional clinical trials (involving medical devices or drugs).
  • Subjects deemed ineligible for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanyan Gong, RN contact

+8615870012276

Gongyy0619@163.com

Ping HU, M.D contact

+8613097286794

hp666edu@163.com

China1 site, 1 recruiting
  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Yanyan Gong, 15870012276, Gongyy0619@163.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Bladder Temperature Monitoring-Guided Targeted Temperature Management in Patients With Severe : A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to learn whether a bladder temperature monitoring-guided targeted temperature management (TTM) strategy improves functional recovery in patients with severe intracerebral hemorrhage, compared to conventional temperature monitoring. It will also assess the safety of this monitoring approach. The main questions it aims to answer are:

  • Does continuous bladder temperature monitoring-guided TTM improve the likelihood of a favorable functional outcome (modified Rankin Scale score 0-2) at 180 days after onset?
  • What medical problems (such as infections, shivering, deep vein thrombosis, or sepsis) do participants experience while under the TTM strategy? Researchers will compare the intervention group (using continuous bladder temperature monitoring) with the control group (using conventional intermittent temperature monitoring with a mercury thermometer at the armpit) to see if the bladder temperature-guided TTM strategy leads to better outcomes.
Read more

Participants will:

  • Be randomly assigned to one of the two temperature monitoring strategies
  • Receive standard medical and surgical care for severe intracerebral hemorrhage
Read the detailed description

Neurogenic fever, a non-infectious febrile condition, is relatively common following severe brain injuries such as intracerebral hemorrhage, aneurysmal subarachnoid hemorrhage, and acute ischemic stroke. Early-onset fever may represent a systemic response to the brain injury itself, whereas late-onset fever is often attributable to severe stroke complications, including infection and deep vein thrombosis (DVT). Fever is positively correlated with illness severity. Substantial evidence confirms that hyperthermia significantly increases the risk of complications-such as rebleeding, exacerbated cerebral edema, seizures-and mortality in patients with intracerebral hemorrhage, and is associated with poor prognosis. Studies have found that mortality and voluntary discharge rates in stroke patients with extreme hyperthermia are six times higher than those in patients with normal body temperature. This underscores the critical importance of timely and effective temperature control and management in stroke patients, which has been shown to reduce mortality and improve neurological outcomes.

Body temperature is a vital sign and a key indicator of health status. Under the regulation of the hypothalamic thermoregulatory center, it fluctuates within a narrow range; deviations beyond this range suggest potential abnormalities [8]. In severe ICH patients, temperature fluctuations not only reflect systemic stress but also serve as a sensitive indicator of intracranial pathological changes, such as hematoma expansion, progressing cerebral edema, and secondary brain injury. However, a critical issue in current clinical practice is the frequent failure to detect temperature changes in severe ICH patients promptly. Typically, significant temperature elevations or reductions are only recognized when they reach extreme levels. This makes it exceptionally difficult to identify the onset of temperature changes, the timing of peaks/troughs, and the effective time of interventions, severely hindering the early recognition of clinical deterioration and timely intervention, potentially missing critical windows for improving outcomes. Therefore, continuous temperature monitoring is crucial for severe ICH patients, particularly given their high fever incidence and elevated risk of secondary brain injury; fever must be identified and managed aggressively upon onset.

Intracranial temperature (ICT) can be measured via direct (e.g., intraparenchymal, intraventricular, subdural catheters) or indirect methods. However, direct measurement is invasive, its application is limited in ICH patients with coagulopathies or high rebleeding risks, and it carries additional risks of hemorrhage or infection. When direct ICT monitoring probes or devices are unavailable, it is recommended to use core temperature measurements from sites that closely approximate and are relatively stable compared to brain temperature. Core temperature measurement sites include the tympanic membrane, temporal artery, rectum, bladder, esophagus, and pulmonary artery. The temperature monitored via a pulmonary artery catheter is considered closest to the true core temperature. Expert consensus on targeted temperature management (TTM) in neurocritical care recommends a preference for brain temperature measurement, followed by esophageal and bladder temperatures. However, esophageal temperature measurement is mildly invasive. Although bladder temperature is recommended by consensus and is known to reliably reflect core temperature trends, in-depth research and direct evidence regarding its application specifically in the high-risk ICH population, particularly rigorous comparative data against the gold standard of intracranial temperature, remain notably scarce.

Given the high fever rate in severe ICH patients, the decisive impact of temperature management on prognosis, the limitations of existing core temperature monitoring methods (especially esophageal) in this population, and the lack of high-quality evidence for bladder temperature monitoring, exploring an accurate, reliable, and practical method for continuous core temperature monitoring suitable for severe ICH patients is of urgent clinical significance. Bladder temperature monitoring offers significant advantages: its readings closely approximate intracranial core temperature trends, enabling real-time reflection of patient temperature fluctuations; it boasts high measurement accuracy and relatively simple operation; it can be implemented via the indwelling urinary catheter routinely placed in severe ICH patients (for monitoring urine output and managing retention), without adding significant nursing workload, avoiding additional invasive procedures, and minimizing patient disturbance, sleep disruption, and treatment interference, while allowing for stable, prolonged placement. More importantly, the continuous monitoring capability of bladder temperature can empower clinicians to grasp the dynamic temperature changes in severe ICH patients in real-time, providing crucial information for the early detection of fever and potential clinical deterioration (e.g., infection, hematoma expansion, worsening cerebral edema), thereby securing a valuable early intervention time window for implementing neuroprotective strategies and complication prevention.

In recent years, bladder temperature monitoring has gained attention in temperature management due to its relative operational simplicity, close approximation to core temperature, and suitability for continuous monitoring. However, current research on using bladder temperature monitoring to guide TTM in neurocritical care patients, specifically those with spontaneous intracerebral hemorrhage, is relatively limited. Existing studies often focus on investigating the impact of TTM itself on patient outcomes or validating the correlation between bladder temperature and traditional monitoring techniques. The updated consensus guidelines from the Neuroprotective Therapy Consensus Review Group emphasize that core temperature is the most important surrogate for intracranial temperature and note that implementing TTM requires reliance on technology capable of real-time, continuous temperature monitoring to precisely regulate body temperature and adjust treatment strategies promptly.

Therefore, this study aims to conduct a randomized controlled trial directly comparing the safety and efficacy of bladder temperature monitoring-guided TTM (intervention group) versus conventional temperature monitoring (axillary temperature)-guided management (control group) in severe ICH patients. The primary efficacy endpoint will assess neurological outcome. Through this research, we seek to evaluate its value in improving key clinical outcomes (neurological recovery) and ensuring patient safety, thereby guiding clinical practice, improving prognosis, and providing new evidence-based medical evidence.

Being tested
Bladder Temperature Monitoring, Standard Temperature Monitoring Group
Keywords
Intracerebral Hemorrhage, Targeted Temperature Management, Bladder Temperature Monitoring
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bladder Temperature MonitoringDevice

    This intervention utilizes a single-use, sterile, thermometric silicone urinary catheter that, upon insertion, provides continuous, real-time measurement of core body temperature, which is used to dynamically guide all phases of Targeted Temperature Management (TTM).

  • Standard Temperature Monitoring GroupDevice

    Axillary temperature is measured intermittently using a mercury-in-glass thermometer. The thermometer is placed in the axilla for a standardized period (e.g., 5-10 minutes) to obtain a reading. Temperature data is recorded every 4 hours and is used to guide adjustments in Targeted Temperature Management (TTM) therapy.

Study groups in NCT07302009
Study groupRoleWhat they receive
Bladder Temperature Monitoring GroupExperimentalPatients in this arm will receive Targeted Temperature Management (TTM) guided by continuous, real-time core temperature monitoring via a bladder thermometer. TTM may include therapeutic hypothermia (TH, 32.0°C ≤ temp < 36.0°C), normothermia control (36.0-37.5°C), or fever treatment, as clinically indicated. Temperature is recorded hourly.
Receives: Device: Bladder Temperature Monitoring
Standard Temperature Monitoring GroupActive comparatorPatients in the control arm will receive Targeted Temperature Management (TTM) guided by intermittent axillary temperature measurements using a mercury-in-glass thermometer, recorded every four hours. TTM may include therapeutic hypothermia, maintenance of normothermia, or treatment of fever, as clinically indicated.
Receives: Device: Standard Temperature Monitoring Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with mRS 0-2 at 180 days post-onset

    The proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0 to 2, at 180 days (±14 days) post-onset. The mRS is a standardized measure of neurological disability ranging from 0 (no symptoms) to 6 (death). A score of 0-2 represents a favorable functional outcome.

    Measured: 180 days post-onset(±14 days)

Secondary outcomes (15)
  1. Daily mean fever burden

    Calculated as the area under the curve (AUC) of temperature above the fever threshold (defined as ≥38.0°C)

    Measured: From enrollment until ICU discharge, meeting hospital discharge criteria, or up to 14 days (336 hours) (whichever occurs first)

  2. Total hospitalization costs

    Measured: From enrollment until hospital discharge

  3. Percentage of patients with mRS 0-2 at 90 days post-onset.

    Measured: 90 days post-onset(±14 days)

  4. Neurological function assessed by GOS at 90 days

    Measured: 90 days post-onset(±14 days)

  5. Neurological function assessed by NIHSS at 90 days

    Measured: 90 days post-onset(±14 days)

  6. Neurological function assessed by GOS at 180 days

    Measured: 180 days post-onset(±14 days)

  7. Neurological function assessed by NIHSS at 180 days

    Measured: 180 days post-onset(±14 days)

  8. Barthel Index scores at 90 and 180 days after onset.

    Measured: 90 (±14 days) and 180 (±14 days) days post-onset

  9. Length of stay in the Intensive Care Unit (ICU)

    Measured: From ICU admission until ICU discharge

  10. Total duration of hospital stay

    Measured: From enrollment until hospital discharge

  11. Infection rate (pneumonia, urinary tract infection)

    Measured: From ICU admission until ICU discharge

  12. DVT Incidence

    Measured: From ICU admission until ICU discharge

  13. Sepsis Incidence

    Measured: From ICU admission until ICU discharge

  14. Malignant Edema Incidence

    Measured: From ICU admission until ICU discharge

  15. All-cause mortality

    Measured: All-cause mortality within 180 days post onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start15 Mar 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Only the outcome assessors and the statistical analysis team will be masked to group allocation. The treating clinicians and patients are unmasked.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
318 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07302009
Sponsor's protocol ID
IIT-I-2025-093
Acronym
BTTM-ICH
Status last verified
Dec 2025
First submitted
11 Dec 2025
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bladder Temperature Monitoring and Standard Temperature Monitoring Group in people with Intracerebral Hemorrhage and Targeted Temperature Management, run by Yanyan Gong at 1 site 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanyan Gong, RN (+8615870012276, Gongyy0619@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with mRS 0-2 at 180 days post-onset (time frame: 180 days post-onset(±14 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jun 2026.

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