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

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

Study Overview

• Status: Completed
• Conditions: Trauma, Multiple
• Intervention / Treatment: Procedure: plasma fibrinogen measurement

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 Type: Observational
• Enrollment (Actual): 280

Contacts and Locations

Study Locations

• Czech Republic
  • Plzen, Czech Republic
    • University Hospital in Plzen
  • Usti nad Labem, Czech Republic, 40001
    • Masaryk hospital in Usti nad Labem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient having / suspected to have severe trauma admitted to participating centres.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trauma patients; All patients having / suspected to have severe trauma injuries admitted to participating centers.	Procedure: plasma fibrinogen measurement; plasma fibrinogen measurement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Masaryk Hospital Krajská zdravotní a.s.
• Investigators: Principal Investigator: Josef Skola, Dr., Masaryk Hospital Usti nad Labem

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma
• Other Study ID Numbers: KAPIM-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No