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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02575989 |
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Date of registration:
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15/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prevention of HYPOthermia in TRAUMa Patients
HYPOTRAUM 2 |
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Scientific title:
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Prevention of HYPOthermia Before Admission in TRAUMa Patients - Hypotraum 2 Study |
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Date of first enrolment:
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January 17, 2016 |
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Target sample size:
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1086 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02575989 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Frédéric LAPOSTOLLE, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion criteria :
- 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
Exclusion criteria :
- Body temperature <31°C or >38°C
- Cardiac arrest before MICU arrival
- Bilateral ear bleeding preventing continuous monitoring of tympanic temperature
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Trauma Patients
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Intervention(s)
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Other: 2: interventional group
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Other: 1: control group
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Primary Outcome(s)
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Number of trauma patients arriving alive with a temperature > 35°C (at receiving hospital)
[Time Frame: Day0]
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Secondary Outcome(s)
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Survival at hospital discharge
[Time Frame: up to 3 months]
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Length of stay at hospital (days)
[Time Frame: up to 3 months]
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Secondary ID(s)
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131204
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2014-A00564-43
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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