Bladder Temperature-Guided Temperature Management in Intracerebral Hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares bladder temperature monitoring-guided targeted temperature management to conventional intermittent temperature monitoring in adults with first-time spontaneous intracerebral hemorrhage. Participants are assessed for functional outcome at 180 days and for safety events such as infections, shivering, and thrombotic or septic complications. The trial uses continuous bladder temperature as an index to adjust targeted temperature management, with standard care serving as the control. Key eligibility includes bilateral assessments of coma level, hematoma size or SAH grade, and prior functional status. Safety and feasibility of the bladder-monitoring approach are primary considerations alongside functional outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Yanyan Gong, RN
• Email: Gongyy0619@163.com
• Phone: +8615870012276

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.