Prevention of HYPOthermia in TRAUMa Patients
HYPOTRAUM 2
Prevention of HYPOthermia Before Admission in TRAUMa Patients - Hypotraum 2 Study
2 other identifiers
interventional
1,086
1 country
1
Brief Summary
The purpose of this study is to demonstrate that the specific management will increase the number of alive trauma patient arriving with a temperature \> 35°C.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedStudy Start
First participant enrolled
January 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2020
CompletedAugust 18, 2020
August 1, 2020
3.7 years
September 15, 2015
August 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of trauma patients arriving alive with a temperature > 35°C (at receiving hospital)
Day0
Secondary Outcomes (2)
Survival at hospital discharge
up to 3 months
Length of stay at hospital (days)
up to 3 months
Study Arms (2)
1: control group
ACTIVE COMPARATORClassic - current management of trauma patients by French medical teams
2: interventional group
EXPERIMENTALIntervention Name : monitoring, treatment, control and prevention of hypothermia * Continuous monitoring of body temperature * Ambulance warming (target : 30°C) * Patient warming with dedicated blanket * Infusion fluid warming (and temperature control)
Interventions
Classic - current management of trauma patients by French medical teams
Intervention Name : monitoring, treatment, control and prevention of hypothermia * Continuous monitoring of body temperature * Ambulance warming (target : 30°C) * Patient warming with dedicated blanket * Infusion fluid warming (and temperature control)
Eligibility Criteria
You may qualify if:
- Patient with trauma (\> 18 years)
- Pre-hospital management by MICU
- Scheduled transfer to a receiving center by a MICU
- And at least one of the following criteria :
- Ambient temperature on the field \< 18°C
- Body temperature \<35°C on MICU arrival
- A Glasgow score \< 15 on MICU arrival
- Systolic blood pressure \< 100 mm Hg on MICU arrival
You may not qualify if:
- \- Body temperature \<31°C or \>38°C
- Cardiac arrest before MICU arrival
- Bilateral ear bleeding preventing continuous monitoring of tympanic temperature
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SAMU 93, AP-HP, Urgences - SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne
Bobigny, 93000, France
Related Publications (1)
Lapostolle F, Sebbah JL, Couvreur J, Koch FX, Savary D, Tazarourte K, Egman G, Mzabi L, Galinski M, Adnet F. Risk factors for onset of hypothermia in trauma victims: the HypoTraum study. Crit Care. 2012 Jul 31;16(4):R142. doi: 10.1186/cc11449.
PMID: 22849694BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric LAPOSTOLLE, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2015
First Posted
October 15, 2015
Study Start
January 17, 2016
Primary Completion
October 16, 2019
Study Completion
January 16, 2020
Last Updated
August 18, 2020
Record last verified: 2020-08