By InvitationNot Applicable

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

France100 participantsStarted 2025-04-05

Plain-language summary

Here's a concise summary in English without the numbers: Hypothermia is defined as a core temperature below 35°C and occurs when the body loses more heat than it produces. It is classified by severity: mild (32-35°C), moderate (28-32°C), and severe (\<28°C). Trauma patients are particularly vulnerable, as hypothermia can affect cardiac, pulmonary, neurological, and coagulation systems, contributing to the "lethal triad" of metabolic acidosis, coagulopathy, and hypothermia, which increases early mortality risk. Shivering, a key sign of hypothermia, significantly raises oxygen consumption, making its prevention during prehospital care critical. Passive warming measures, such as insulating survival blankets, are commonly used to prevent heat loss in emergencies. These blankets help maintain body temperature, protecting victims from cold and wind. Hypothermia prevalence among trauma patients on hospital arrival is high, emphasizing the importance of prehospital measures to limit its impact. However, active warming systems are often impractical in prehospital settings, leaving passive methods as the primary strategy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Statistical distribution of the temperature evolution

Timeframe: From the intervention of the medical team on site until discharge from the hospital (1 month maximum)

Trial details

NCT IDNCT06788925

SponsorThermoTrauma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-30

View on ClinicalTrials.gov More Hypothermia Due to Cold Environment trials