Predictors of Hypofibrinogenemia in Severe Trauma

Severe Trauma Clinical Trial

Official title:

Can we Define a Clinical Score for Predicting of Hypofibrinogenemia in Severe Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020849
• Other study ID #: 69HCL17_0015
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: July 27, 2017
• Start date: January 2011
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen <1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1038
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18

• severe trauma

Exclusion Criteria:

• age <18

Related Conditions & MeSH terms

• Severe Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
France	HEH - Hospices Civils de Lyon	Lyon
France	CHLS, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of fibrinogen in blood sample at hospitalisation	This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation	day 0 (at hospitalisation)