Polytrauma Clinical Trial
— PRETICOfficial title:
Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.
Verified date | January 2024 |
Source | Banc de Sang i Teixits |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.
Status | Completed |
Enrollment | 79 |
Est. completion date | January 11, 2022 |
Est. primary completion date | January 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age =18 years AND - Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND - Evidence of bleeding or a high bleeding suspicion according to physician judgment OR - Predicted to need transfusion according to TICCS score =10 Exclusion Criteria: - Moribund patient with devastating injuries and expected to die within 1-hour OR - Known objection to blood components transfusion OR - Known acquired or congenital coagulopathies not related to the actual trauma OR - Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR - Known Pregnancy OR - Severe isolated traumatic brain injury OR - Hemorrhage not related to the actual trauma |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Josep Trueta | Girona |
Lead Sponsor | Collaborator |
---|---|
Banc de Sang i Teixits |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC) | TEG6s(R) parameters that define TIC | Basal (at the crash site) | |
Primary | TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC) | TEG6s(R) parameters that define TIC | Basal (at the hospital arrival) | |
Primary | All-cause mortality | Mortality for any cause | 1 hour post hospital admission | |
Primary | All-cause mortality | Mortality for any cause | 6 hours post hospital admission | |
Primary | All-cause mortality | Mortality for any cause | 24 hours post hospital admission | |
Primary | Accountability | Red bood cells concentrate accountability | 30 days | |
Primary | Temperature storage conditions of the red blood cells concentrate | Red bood cells concentrate out of temperature range for storage | 24 hours | |
Secondary | All-cause mortality | Mortality for any cause | 48 hours post hospital admission | |
Secondary | All-cause mortality | Mortality for any cause | 30 days post hospital admission | |
Secondary | Adverse Events | Treatment emergent adverse events | 30 days post hospital admission (or previously at hospital discharge) | |
Secondary | Thromboembolism events | Thromboembolism events | 30 days | |
Secondary | Crystalloid fluid requirements | Volume of crystalloids required | 1 hour (from the crash site to the hospital admission) | |
Secondary | Crystalloid fluid requirements | Volume of crystalloids required | 30 days post hospital admission (or previously at hospital discharge) | |
Secondary | Transfusion requirements | Transfusion requirements of RBC, platelets and plasma | 24 hours (or previously at discharge of the emergency room) | |
Secondary | Transfusion requirements | Transfusion requirements of RBC, platelets and plasma | 30 days post hospital admission (or previously at hospital discharge) | |
Secondary | Water balance | Water balance at the Intensive Care Unit (ICU) | 24 hours of admission at the ICU | |
Secondary | Water balance | Water balance at the Intensive Care Unit (ICU) | 72 hours of admission at the ICU | |
Secondary | Ventilator-free days | Ventilator-free days at the ICU | 30 days |
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