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CompletedNCT02619539SIDEUpdated Mar 24, 2017

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

An observational study in Trauma, Multiple, sponsored by Masaryk Hospital Krajská zdravotní a.s.. Completed at 2 sites in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Masaryk Hospital Krajská zdravotní a.s. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
280
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Trauma, Multiple
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
280 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Trauma patients

    All patients having / suspected to have severe trauma injuries admitted to participating centers.

    Procedure: plasma fibrinogen measurement

Interventions

  • Procedureplasma fibrinogen measurement

    plasma fibrinogen measurement

05

What researchers measure

Primary outcomes

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

    Time frame: On admission

06

Study locations

2 sites
  • University Hospital in Plzen
    Plzen, Czech Republic
  • Masaryk Hospital in Usti nad Labem
    Usti nad Labem, 40001, Czech Republic
07

References and documents

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. PubMed 24666991 ↗
  • 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. PubMed 23601765 ↗
  • 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. PubMed 21965371 ↗
  • 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. PubMed 22364525 ↗
  • 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. PubMed 23849249 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT02619539
Lead sponsor
Masaryk Hospital Krajská zdravotní a.s.
Responsible party
Josef Skola (Dr., Masaryk Hospital Krajská zdravotní a.s.) — Principal investigator
First posted
Dec 2, 2015
Start date
Jan 2016
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Last update
Mar 24, 2017

Study contacts

Josef Skola, Dr.
principal investigator · Masaryk Hospital Usti nad Labem

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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