Capillary Lactate and Transfusion Needs

Completed

• Conditions: Trauma
• Interventions: Other: Capillary lactate level

• Registration Number: NCT01793428
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-02
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Injured patient admitted in vital emergency unit	Capillary lactate level	-

Primary Outcome Measures

Name	Time	Method
Transfusion of 6 or more units of packed Red Blood Cells (RBC)	48 hours

Secondary Outcome Measures

Name	Time	Method
injury scores (ISS,SOFA)	24h
arterial lactate measures	upon arrival at the vital emergency unit
blood lactate measure	upon arrival at vital emergency unit
Intensity of medical care	upon arrival at vital emergency unit	Body scan Central venous catheterisation arterial catheterisation
Bleeding Predictive Score	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?
Mortality	28 days
transfusion of 4 units of packed RBC	48 hours

Trial Locations

Locations (1)

Grenoble University Hospital; 🇫🇷 La Tronche, Isere, France