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

Trauma, Multiple Clinical Trial

— SIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619539
• Other study ID #: KAPIM-1
• Status: Completed
• Phase: N/A
• First received: November 30, 2015
• Last updated: March 22, 2017
• Start date: January 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2017
• Source: Masaryk Hospital Krajská zdravotní a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Trauma
• Trauma, Multiple
• Wounds and Injuries

Intervention

Procedure:
• plasma fibrinogen measurement
plasma fibrinogen measurement

Locations

Country	Name	City	State
Czech Republic	University Hospital in Plzen	Plzen
Czech Republic	Masaryk Hospital in Usti nad Labem	Usti nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Hospital Krajská zdravotní a.s.

Country where clinical trial is conducted

Czech Republic, 

References & Publications (5)

Hagemo JS, Stanworth S, Juffermans NP, Brohi K, Cohen M, Johansson PI, Røislien J, Eken T, Næss 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. — View 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. Review. — View Citation

Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schöchl 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. — View Citation

Schöchl H, Maegele M, Solomon C, Görlinger 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. Review. — View Citation

Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernández-Mondéjar 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.		On admission