Capillary Lactate and Transfusion Needs

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793428
• Other study ID #: 2012-19
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: April 2, 2015
• Start date: August 2011

Study information

• Verified date: April 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Trauma

Intervention

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

Locations

Country	Name	City	State
France	Grenoble University Hospital	La Tronche	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion of 6 or more units of packed Red Blood Cells (RBC)		48 hours	No
Secondary	arterial lactate measures		upon arrival at the vital emergency unit	No
Secondary	injury scores (ISS,SOFA)		24h	No
Secondary	transfusion of 4 units of packed RBC		48 hours	No
Secondary	blood lactate measure		upon arrival at vital emergency unit	No
Secondary	Intensity of medical care	Body scan Central venous catheterisation arterial catheterisation	upon arrival at vital emergency unit	No
Secondary	Bleeding Predictive Score	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	No
Secondary	Mortality		28 days	No