Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

Severe Trauma Clinical Trial

— Coaguchek  

Official title:

Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869737
• Other study ID #: CECIC 2015-03
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 12, 2016
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: CECIC Rhône-Alpes-Auvergne, Clermont Ferrand, France:
• Study type: Observational

Clinical Trial Summary

Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (INR). These tests are not available at the bedside. Point of care (POC) device for INR measurement are now available like the Coaguchek, Roche, France. The aim of the present study is to test the correlation between the POC INR and the laboratory INR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Age > 15 y-o

• Admission for severe trauma

Exclusion Criteria:

• Patients under oral anticoagulant

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Severe Trauma
• Wounds and Injuries

Intervention

Device:
• Coagucheck, Roche, France
Capillary puncture for POC INR measurement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5		Admission	No
Secondary	Prediction of RBC transfusion		24 hours post admission	No
Secondary	Prediction of FFP transfusion		24 hours post admission	No
Secondary	In-hospital mortality assessed using patients' files		up to Day 28	No
Secondary	Injury severity (ISS)		Day 1	No
Secondary	Organ failure measured with the SOFA score at Day 1		Day 1	No