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NCT06788925
Clinical Evaluation of Effectiveness of the "Therm'Up" Heating Device
NA trial testing Patients support with survival coverage in Hypothermia Due to Cold Environment in 100 participants. Enrolling by invitation.
30 March 2026
Quick facts
| Lead sponsor | ThermoTrauma |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 5 April 2025 |
| Primary completion | 30 March 2026 |
| Estimated completion | 30 March 2026 |
| Sites | 1 location across France |
Drugs / interventions tested
- Patients support with survival coverage
- Patients support with active thermic jacket
Conditions studied
- Hypothermia Due to Cold Environment — all drugs for Hypothermia Due to Cold Environment →
Sponsor
ThermoTrauma
Who can join
18 and older, any sex, with Hypothermia Due to Cold Environment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06788925
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06788925 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ThermoTrauma
- Last refreshed: 14 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06788925.
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