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

Masaryk Hospital Krajská zdravotní a.s.

Status: Completed

Conditions: Trauma, Multiple

Treatments: Procedure: plasma fibrinogen measurement

Study type: Observational

Funder types: Other

Identifiers

NCT02619539

KAPIM-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

280 participants in 1 patient group

Trauma patients

Description:

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

Treatment:

Procedure: plasma fibrinogen measurement