Capillary Lactate and Transfusion Needs

NCT01793428 | Completed

• 1 other identifier: 2012-19
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

adults admitted in vital emergency unit

Outcome Measures

Primary Outcomes (1)

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

  48 hours

Secondary Outcomes (7)

• arterial lactate measures

  upon arrival at the vital emergency unit

• injury scores (ISS,SOFA)

  24h

• transfusion of 4 units of packed RBC

  48 hours

• blood lactate measure

  upon arrival at vital emergency unit

• Intensity of medical care

  upon arrival at vital emergency unit

Study Arms (1)

Injured patient admitted in vital emergency unit

Other: Capillary lactate level

Interventions

Capillary lactate level OTHER

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

Injured patient admitted in vital emergency unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

La Tronche, Isere, 38700, France

Location

Related Publications (1)

• Bouzat P, Schilte C, Vinclair M, Manhes P, Brun J, Bosson JL, Payen JF. Capillary lactate concentration on admission of normotensive trauma patients: a prospective study. Scand J Trauma Resusc Emerg Med. 2016 Jun 7;24:82. doi: 10.1186/s13049-016-0272-x.

  PMID: 27267942 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Marc Vinclair, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: August 1, 2011
• Primary Completion: February 1, 2013
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

FR (1)