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Completed

NCT Number: NCT02619539

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

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

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Key information

Conditions

Trauma, Multiple Multiple Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital in Plzen, Pilsen, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

plasma fibrinogen measurement

Procedure

plasma fibrinogen measurement

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

Sponsors and collaborators

Lead sponsor

Masaryk Hospital Krajská zdravotní a.s.

Other

Registry information

Acronym: SIDE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2015
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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