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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02619539
Other study ID # KAPIM-1
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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