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Capillary Lactate and Transfusion Needs

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ClinicalTrials.gov Identifier: NCT01793428
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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.


Condition or disease Intervention/treatment
Trauma Other: Capillary lactate level

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictive Abilities for Transfusion Needs of Capillary Lactate Measure in Emergency for Injured Normotensive Patients
Study Start Date : August 2011
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Transfusion of 6 or more units of packed Red Blood Cells (RBC) [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793428


Locations
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France
Grenoble University Hospital
La Tronche, Isere, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Marc Vinclair, MD University Hospital, Grenoble

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01793428    
Other Study ID Numbers: 2012-19
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by University Hospital, Grenoble:
adults admitted in vital emergency unit