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Safety and Efficacy of Bladder Temperature Monitoring-Guided Targeted Temperature Management in Patients With Severe : A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Contact Information
Primary
Yanyan Gong, RN
Gongyy0619@163.com
+8615870012276
Backup
Ping HU, M.D
hp666edu@163.com
+8613097286794
Time Frame
Start Date: 2026-03-15
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 318
Treatments
Experimental: Bladder Temperature Monitoring Group
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.
Active_comparator: Standard Temperature Monitoring Group
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.
Sponsors
Collaborators: The First People's Hospital of Changde City, Zhejiang University, First Affiliated Hospital of Gannan Medical University, Renmin Hospital of Wuhan University, The First People's Hospital of Xiushui, Yichang Central People's Hospital, Xiangya Hospital of Central South University
Leads: Yanyan Gong

This content was sourced from clinicaltrials.gov