Targeted Temperature Management Via Bladder Monitoring in ICH

Recruiting now · Not applicable

Conditions studied: Intracerebral Hemorrhage, Targeted Temperature Management

In brief

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. Participants will: * Be randomly assigned to one of the two temperature monitoring strategies * Receive standard medical and surgical care for severe intracerebral hemorrhage

Key facts

Study ID

NCT07302009

Run by

Yanyan Gong

People needed

318

Starts

2026-03-15

Expected to finish

2027-12-30

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)

Full record on ClinicalTrials.gov

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