Completed

Predictive Abilities for Transfusion Needs of Capillary Lactate Measure in Emergency for Injured Normotensive Patients

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What is being collected

Data Collection

Collected from today forward - Prospective
Other
Who is being recruted

Wounds and Injuries

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: August 2011
See protocol details

Summary

Principal SponsorUniversity Hospital, Grenoble
Last updated: April 3, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2011

Actual date on which the first participant was enrolled.

13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion of six or more units of packed Red Blood Cells. It is currently difficult to predict the need for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and blood pressure can be normal during the first hours despite intensive bleeding. It's well known that blood or arterial lactate measures correlate with trauma severity but these measures are not available in a pre-hospital setting. The investigators want to test whether capillary lactate measures also correlate with trauma severity and can therefore predicts earlier transfusion needs.

NCT01793428
Principal SponsorUniversity Hospital, Grenoble
Last updated: April 3, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Wounds and Injuries

Criteria

5 inclusion criteria required to participate
Adult admitted in vital emergency unit
Severe trauma
normotensive (Systolic Blood Pressure > 90mmHg)
patient beneficiary of social security
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6 exclusion criteria prevent from participating
Nor epinephrine > 0.1gamma/kg/min
hypothermia below 35°C
liver deficiency
pre-hospital transfusion
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Grenoble University Hospital

La Tronche, FranceOpen Grenoble University Hospital in Google Maps
CompletedOne Study Center