Coagulopathy, Massive Hemorrhage, Trauma, Multiple
Conditions
Keywords
trauma-induced coagulopathy
Brief summary
Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR). POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.
Interventions
PROCEDURETrauma-induced coagulopathy treatment
Transfusion as needed according to the assay methodology
Sponsors
A.O. Ospedale Papa Giovanni XXIII
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pragmatic randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
all adult (\> 18 years old) trauma patients treated in our Emergency Department with a TASH score \> 18
Exclusion criteria
* dead on arrival * no blood product administered after randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fresh frozen plasma consumption | 3 years | In the POC group plasma consumption is estimated 20% less than in conventional assays group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28 days | 28 days mortality |
Countries
Italy
Outcome results
None listed