Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02619539
Acronym
SIDE
Enrollment
280
Registered
2015-12-02
Start date
2016-01-31
Completion date
2017-02-28
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma, Multiple

Brief summary

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

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.

Interventions

PROCEDUREplasma fibrinogen measurement

plasma fibrinogen measurement

Sponsors

Masaryk Hospital Krajská zdravotní a.s.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026