Targeted Temperature Management Via Bladder Monitoring in ICH

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

Conditions

• Intracerebral Hemorrhage
• Targeted Temperature Management

Interventions

DEVICE

Bladder Temperature Monitoring

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).

DEVICE

Standard Temperature Monitoring Group

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.

Sponsors & Collaborators

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• The First People's Hospital of Changde City

  collaborator OTHER

• The First People's Hospital of Xiushui

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Yanyan Gong

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-20

Primary Completion

2027-12-30

Completion

2027-12-30