Targeted Temperature Management Via Bladder Monitoring in ICH

NCT07302009 | Not Yet Recruiting DMC

• 1 other identifier: IIT-I-2025-093
• Study Type: interventional
• Target: 308
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Intracerebral Hemorrhage; Targeted Temperature Management; Bladder Temperature Monitoring

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with mRS 0-2 at 180 days post-onset

  The proportion of participants achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0 to 2, at 180 days (±14 days) post-onset. The mRS is a standardized measure of neurological disability ranging from 0 (no symptoms) to 6 (death). A score of 0-2 represents a favorable functional outcome.

  180 days post-onset（±14 days）

Secondary Outcomes (15)

• Daily mean fever burden

  From enrollment until ICU discharge, meeting hospital discharge criteria, or up to 14 days (336 hours) (whichever occurs first)

• Total hospitalization costs

  From enrollment until hospital discharge

• Percentage of patients with mRS 0-2 at 90 days post-onset.

  90 days post-onset（±14 days）

• Neurological function assessed by GOS at 90 days

  90 days post-onset（±14 days）

• Neurological function assessed by NIHSS at 90 days

  90 days post-onset（±14 days）

Study Arms (2)

Bladder Temperature Monitoring Group

EXPERIMENTAL

Patients in this arm will receive Targeted Temperature Management (TTM) guided by continuous, real-time core temperature monitoring via a bladder thermometer. TTM may include therapeutic hypothermia (TH, 32.0°C ≤ temp \< 36.0°C), normothermia control (36.0-37.5°C), or fever treatment, as clinically indicated. Temperature is recorded hourly.

Device: Bladder Temperature Monitoring

Standard Temperature Monitoring Group

ACTIVE COMPARATOR

Patients in the control arm will receive Targeted Temperature Management (TTM) guided by intermittent axillary temperature measurements using a mercury-in-glass thermometer, recorded every four hours. TTM may include therapeutic hypothermia, maintenance of normothermia, or treatment of fever, as clinically indicated.

Device: Standard Temperature Monitoring Group

Interventions

Bladder Temperature Monitoring DEVICE

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).

Bladder Temperature Monitoring Group

Standard Temperature Monitoring Group DEVICE

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.

Standard Temperature Monitoring Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Yanyan Gong: lead
• 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

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yanyan Gong, RN

CONTACT

+8615870012276; Gongyy0619@163.com

Ping HU, M.D

CONTACT

+8613097286794; hp666edu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcome assessors and the statistical analysis team will be masked to group allocation. The treating clinicians and patients are unmasked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Nurse, Department of Neurosurgery, The Second Affiliated Hospital of Nanchang University

Model Details: Only the outcome assessors and the statistical analysis team will be masked to group allocation. The treating clinicians and patients are unmasked.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share