Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)

Completed

• Conditions: Trauma, Multiple
• Interventions: Procedure: plasma fibrinogen measurement

• Registration Number: NCT02619539
• Lead Sponsor: Masaryk Hospital Krajská zdravotní a.s.

Brief Summary

Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.

Detailed Description

Hypofibrinogenemia is common in severe trauma and below the threshold of 2.3 g/l is associated with increased mortality. Although guidelines for management of the trauma induced coagulopathy does not recommend any specific timing of fibrinogen substitution, several papers suggest that early substitution might be associated with improved outcome. Laboratory measurement of plasma fibrinogen level, thromboelastometry and/or its estimation based on base excess, hemoglobin level, Injury Severity Score or combinations require diagnostic procedures that are associated with with a certain time delay and prolongs the time to fibrinogen substitution.

Study Timeline

• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Study Start: 2016-01
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations

Exclusion Criteria

• possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy)
• administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level
• circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trauma patients	plasma fibrinogen measurement	All patients having / suspected to have severe trauma injuries admitted to participating centers.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.	On admission

Trial Locations

Locations (2)

University Hospital in Plzen; 🇨🇿 Plzen, Czech Republic

Masaryk Hospital in Usti nad Labem; 🇨🇿 Usti nad Labem, Czech Republic