Capillary Lactate and Transfusion Needs | NCT01793428

Studies
Capillary Lactate and Transfusion Needs

NCT01793428

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Apr 3, 2015Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Trauma

Interventions

Capillary lactate level

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Not provided

First Submitted Date

Feb 12, 2013

First Submission Date that Met QC Criteria

Feb 14, 2013

First Posted Date

Feb 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2015

Last Update Posted Date

Apr 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Injured patient admitted in vital emergency unit			Other: Capillary lactate level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transfusion of 6 or more units of packed Red Blood Cells (RBC)		48 hours

Secondary Outcomes

Measure	Description	Time Frame
arterial lactate measures		upon arrival at the vital emergency unit
injury scores (ISS,SOFA)		24h
transfusion of 4 units of packed RBC

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults admitted in vital emergency unit due to severe trauma based on a local severity score.

Patients are normotensive

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Vinclair, MD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grenoble University Hospital		La Tronche	Isere	38700	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27267942	Derived	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.