Clinical trial NCT02619539: Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)
Official title: Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma, Multiple
Lead sponsor: Masaryk Hospital Krajská zdravotní a.s.
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient having / suspected to have severe trauma admitted to participating centres.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.
timeFrame: On admission
Secondary outcomes:
Other outcomes:
Locations:
city: Plzen
country: Czech Republic
facility: University Hospital in Plzen
city: Usti nad Labem
country: Czech Republic
facility: Masaryk Hospital in Usti nad Labem
Study officials:
affiliation: Masaryk Hospital Usti nad Labem
name: Josef Skola, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hagemo JS, Stanworth S, Juffermans NP, Brohi K, Cohen M, Johansson PI, Roislien J, Eken T, Naess PA, Gaarder C. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study. Crit Care. 2014 Mar 26;18(2):R52. doi: 10.1186/cc13798.
citation: Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013 Apr 19;17(2):R76. doi: 10.1186/cc12685.
citation: Levy JH, Szlam F, Tanaka KA, Sniecienski RM. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg. 2012 Feb;114(2):261-74. doi: 10.1213/ANE.0b013e31822e1853. Epub 2011 Sep 29.
citation: Schochl H, Maegele M, Solomon C, Gorlinger K, Voelckel W. Early and individualized goal-directed therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2012 Feb 24;20:15. doi: 10.1186/1757-7241-20-15.
citation: Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schochl H. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013 Jul 12;17(4):R137. doi: 10.1186/cc12816.