Clinical Trial

Targeted Temperature Management Via Bladder Monitoring in ICH

Study acronym: BTTM-ICH
Recruiting
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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. 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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-11.
Status change: Not Yet Recruiting → Recruiting 2026-06-07
Trial Details
NCT Number NCT07302009
Lead Sponsor Yanyan Gong
Collaborators: First Affiliated Hospital of Gannan Medical University, Xiangya Hospital of Central South University, Renmin Hospital of Wuhan University, First Affiliated Hospital of Zhejiang University, The First People's Hospital of Changde City, The First People's Hospital of Xiushui, Yichang Central People's Hospital
Conditions Intracerebral Hemorrhage, Targeted Temperature Management
Enrollment 318 participants
Start Date 2026-03-15
Primary Completion 2027-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-10