About this 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.
Participants will:
* Be randomly assigned to one of the two temperature monitoring strategies * Receive standard medical and surgical care for severe intracerebral hemorrhage
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Bladder Temperature Monitoring
- Standard Temperature Monitoring Group
Treatment groups
Locations
1Sponsors and collaborators
Yanyan Gong
Lead sponsor
Second Affiliated Hospital of Nanchang University
Sponsor institution
First Affiliated Hospital of Gannan Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Zhejiang University
Collaborator
The First People's Hospital of Changde City
Collaborator
The First People's Hospital of Xiushui
Collaborator
Yichang Central People's Hospital
Collaborator