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Completed

NCT Number: NCT01793428

Capillary Lactate and Transfusion Needs

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.

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Key information

Conditions

Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grenoble University Hospital

La Tronche, Isere, 38700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capillary lactate level

Other

Use of capillary sample to determine lactate level upon arrival at vital emergency unit and at 2 hours

Primary outcomes

  1. Transfusion of 6 or more units of packed Red Blood Cells (RBC)

    Time frame: 48 hours

Secondary outcomes

  1. arterial lactate measures

    Time frame: upon arrival at the vital emergency unit

  2. injury scores (ISS,SOFA)

    Time frame: 24h

  3. transfusion of 4 units of packed RBC

    Time frame: 48 hours

  4. blood lactate measure

    Time frame: upon arrival at vital emergency unit

  5. Intensity of medical care

    Time frame: upon arrival at vital emergency unit

    Body scan Central venous catheterisation arterial catheterisation

  6. 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?

  7. Mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
First posted
Feb 15, 2013
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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