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

N/ACompletedNCT02619539

Masaryk Hospital Krajská zdravotní a.s.280 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

280

Conditions

Trauma, Multiple

Interventions

plasma fibrinogen measurementPROCEDURE

plasma fibrinogen measurement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

University Hospital in Plzen

Pilsen, Czechia

Masaryk Hospital in Usti nad Labem

Ústí nad Labem, Czechia

Outcomes

Primary Outcomes

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

Time frame: On admission

Data from ClinicalTrials.gov

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