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Search / Trial NCT06788925

Clinical Evaluation of Effectiveness of the "Therm'Up" Heating Device

Launched by DALIA CARE · Jan 17, 2025

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Hypothermia Lifejacket Active Device

ClinConnect Summary

This clinical trial is studying the effectiveness of a device called "Therm'Up," which is designed to help warm patients who are suffering from hypothermia due to cold environments. Hypothermia happens when the body gets too cold, and it can be especially dangerous for trauma patients. The trial aims to see if this new device can improve the warming process in patients who are at risk of hypothermia after an injury, particularly those who are exposed to cold or have severe injuries.

To be eligible for this trial, participants need to be at least 18 years old and may include individuals with certain types of trauma, those who have been exposed to cold, or patients who have significant bleeding. However, some individuals, such as those with specific injuries or conditions, pregnant or breastfeeding women, and those already involved in other clinical trials, will not be able to participate. If selected, participants will be monitored and treated with the Therm'Up device during their prehospital care, and researchers will gather information on how well it works to help warm them up safely.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years; Confi dential Page 7on 11 Version No. 2.0 of 2024/12/10
  • Patient at risk of hypothermia presenting with grade A, or B, or C trauma or patient with hypothermia;
  • Patient exposed to cold;
  • Patient with hemorrhage;
  • Patient burned over 20% of body surface area;
  • Patient requiring an intervention delay of more than 30 minutes (between the arrival of the medical team on site and arrival at the hospital)
  • Exclusion Criteria:
  • Patient with known ongoing hyperthermia and/or infections or body injuries such as burns in the area where the breastplate is positioned;
  • Patient presenting with cardiac arrest before the arrival of the team;
  • Patient with bilateral aural bleeding preventing continuous monitoring of the eardrum;
  • Patient covered with insulating bubble wrap;
  • Pregnant or breastfeeding woman;
  • Patient already participating in an interventional clinical trial;
  • Patient not receiving social security benefi ts;
  • Adult patient subject to a legal protection measure, guardianship or deprived of liberty by a judicial or administrative decision.

About Dalia Care

Dalia Care is a dedicated clinical trial sponsor focused on advancing healthcare through innovative research and development. Committed to enhancing patient outcomes, Dalia Care specializes in designing and implementing clinical trials that address unmet medical needs across various therapeutic areas. With a robust team of experts and a patient-centered approach, the organization strives to foster collaboration among stakeholders, ensuring the highest standards of safety and efficacy in its studies. Dalia Care aims to bridge the gap between scientific discovery and practical application, ultimately contributing to the advancement of medical knowledge and the improvement of patient care worldwide.

Locations

Echirolles, , France

Patients applied

0 patients applied

Trial Officials

Thomas Spadoni

Study Director

Thermotrauma SAS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported