Prevention of HYPOthermia in TRAUMa Patients (HYPOTRAUM 2)

August 17, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Prevention of HYPOthermia Before Admission in TRAUMa Patients - Hypotraum 2 Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Trauma patients are often hypothermic (temperature < 35 °C) upon arrival at the hospital. Hypothermia is with hypotension and hypoxia, perfectly known to be directly responsible for complications.

Hypothermia is responsible, with acidosis and coagulopathy, of the " lethal triad" of trauma.

Thus, it is clearly established that hypothermia is directly associated with poor prognostic in trauma patients. In a recent study, mortality rate reached 100% for trauma patients arriving at the hospital with a body temperature below 32°C.

The weather, the severity of the trauma and medical (or paramedical) interventions are responsible for the onset of this hypothermia.

Then, continuous monitoring of the patient's temperature, active protection against hypothermia with a metal blanket, the warming (and measure the temperature of) infusion fluids, the warming (and measure the temperature of) the ambulance should improve patient's outcome. As hypothermia is associated with mortality of trauma patients, the control must lead to reduce mortality.

Randomization Due to the use of a global management strategy with combination of several specific interventions and the need for special equipment (heating devices infusion fluids), randomization will be done by investigator center: interventional center (combining the different interventions) and standard management (without modification, except measurements of the patient's and air temperature at inclusion and on arrival at a receiving center.

In this context, it is also crucial that the weather conditions, the characteristics of trauma and patients were similar in both groups. Also, 12 investigation centers will be classified based on annual local average temperatures.

Main collected data Demographics and morphological traits (age, sex, body weight, and height of the victim), the nature and circumstances of the accident (date, time, place), the victim's presentation on mobile intensive care unit (MICU) arrival (trapped or not, seated or lying down, on the ground, unclothed, wet, or covered by a blanket, environmental conditions, clinical factors, and care provided.

Environmental conditions included air (indoors or outdoors) temperature, and rain at the site of the accident as well as mobile intensive care unit temperature.

Clinical factors included: the site and nature of the lesions (fracture, wound, contusion), heart rate, the Revised Trauma Score (RTS) (Glasgow Coma Score (GCS) + systolic blood pressure + respiratory rate), oxygen saturation or oxygen delivery, and tympanic temperature.

Whenever applicable: vascular filling (infusion fluid temperature and volumes), catecholamine and morphine administration, any other drugs (with doses), orotracheal intubation.

Times from the accident to MICU arrival and from MICU arrival to hospital admission.

Statistical analysis Primary endpoint: rate of patients arriving at the hospital with a temperature <35°C. These data will be analyzed by model of multi-level logistic regression to again consider the cluster design of the study. A secondary analysis will enter the model known a priori factors that may affect hypothermia. The parameters corresponding to the secondary objectives will be entered in a model of logistic regression multivariate thereby specifically test their effect on the criteria studied.

Secondary endpoints: Binary secondary endpoints will be analyzed by model of multi-level logistic regression. Quantitative secondary endpoints will be analyzed by mixed model ANCOVA introducing randomness in the center. The variables may be processed before analysis for non-Gaussian distribution. In case of failure of the normalizing transformation, exact procedure may be used.

Number of patients to include The calculation of the sample size was based on our previous study.* The incidence of hypothermia on arrival at the hospital was 14%. By selecting high-risk patients, the investigators expect an incidence of about 20%. The objective is to achieve a reduction of one third of hypothermia (i.e. from 20 to 13 %). Using a two-tailed test at α risk of 0.05 and 1 - beta 0.8, the calculation of required number of patients is 440 per group. Assuming a moderate inflation factor of about 1.35 related to the cluster randomization (our experience shows that intra-cluster correlation coefficients are low) the total number of patients per group will be 600 patients.

A total of N = 1,200 patients for the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1086

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93000
        • SAMU 93, AP-HP, Urgences - SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 1: control group
Classic - current management of trauma patients by French medical teams
Other: 1: control group
Classic - current management of trauma patients by French medical teams
EXPERIMENTAL: 2: interventional group

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)
Other: 2: interventional group

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of trauma patients arriving alive with a temperature > 35°C (at receiving hospital)
Time Frame: Day0
Day0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Survival at hospital discharge
Time Frame: up to 3 months
up to 3 months
Length of stay at hospital (days)
Time Frame: up to 3 months
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frédéric LAPOSTOLLE, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 131204
  • 2014-A00564-43 (OTHER: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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