Capillary Lactate and Transfusion Needs

April 2, 2015 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

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
    • Isere
      • La Tronche, Isere, France, 38700
        • Grenoble University Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults admitted in vital emergency unit due to severe trauma based on a local severity score.

Patients are normotensive

Description

Inclusion Criteria:

  • Adult admitted in vital emergency unit
  • Severe trauma
  • normotensive (Systolic Blood Pressure >90mmHg)
  • patient subjected to capillary haemoglobin and glucose measurements
  • patient beneficiary of social security

Exclusion Criteria:

  • pregnant woman
  • liver deficiency
  • pre-hospital transfusion
  • hypothermia below 35°C
  • protected persons according to the law
  • Nor epinephrine > 0.1gamma/kg/min

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Injured patient admitted in vital emergency unit
Other: Capillary lactate level
Use of capillary sample to determine lactate level upon arrival at vital emergency unit and at 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transfusion of 6 or more units of packed Red Blood Cells (RBC)
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
28 days
arterial lactate measures
Time Frame: upon arrival at the vital emergency unit
upon arrival at the vital emergency unit
injury scores (ISS,SOFA)
Time Frame: 24h
24h
transfusion of 4 units of packed RBC
Time Frame: 48 hours
48 hours
blood lactate measure
Time Frame: upon arrival at vital emergency unit
upon arrival at vital emergency unit
Intensity of medical care
Time Frame: upon arrival at vital emergency unit
Body scan Central venous catheterisation arterial catheterisation
upon arrival at vital emergency unit
Bleeding Predictive Score
Time Frame: upon arrival at vital emergency unit
3 questions are asked to the doctor in emergency room. Could patient be admitted directly at the CT scan ? Do you think that the patient need transfusion ? If Yes : and how many units ? Do you think that the patient will be hospitalized in an intensive care unit after the emergency room?
upon arrival at vital emergency unit

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Marc Vinclair, MD, University Hospital, Grenoble

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

August 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-19

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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