Clinical trial NCT03780894: Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Polytrauma
Traumatic Hemorrhage
Keywords: Polytrauma
Red blood cells transfusion
Acute traumatic hemorrhage
Lead sponsor: Banc de Sang i Teixits
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial.

The experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A pilot, non-randomized, open-label study of two intervention arms and controlled with the standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma will enter the study with the main objective of evaluating the feasibility and the efficacy of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen concentrate and tranexamic acid (experimental arm) compared to the standard treatment based on crystalloids administration and tranexamic acid (control arm). The secondary objectives are to evaluate the safety and clinical evolution of the patients. Prior to the administration of the treatment, 2 blood samples will be extracted in both groups in order to compare the coagulation status and to be able to perform the pre-transfusion tests. On arrival at the hospital, another sample will be taken to compare changes in coagulation after the administration of the experimental or standard treatment and also between both groups. The assessment of the coagulation status will be made using the values provided by the viscoelastic test (TEG6s). The experimental and standard treatment will be administered endovenously. After treatment, patients will be evaluated up to 30 days.

Eligibility criteria: 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

Primary outcomes:
measure: TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
timeFrame: Basal (at the crash site)
measure: TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
timeFrame: Basal (at the hospital arrival)
measure: All-cause mortality
timeFrame: 1 hour post hospital admission
measure: All-cause mortality
timeFrame: 6 hours post hospital admission
measure: All-cause mortality
timeFrame: 24 hours post hospital admission
measure: Accountability
timeFrame: 30 days
measure: Temperature storage conditions of the red blood cells concentrate
timeFrame: 24 hours
Secondary outcomes:
measure: All-cause mortality
timeFrame: 48 hours post hospital admission
measure: All-cause mortality
timeFrame: 30 days post hospital admission
measure: Adverse Events
timeFrame: 30 days post hospital admission (or previously at hospital discharge)
measure: Thromboembolism events
timeFrame: 30 days
measure: Crystalloid fluid requirements
timeFrame: 1 hour (from the crash site to the hospital admission)
measure: Crystalloid fluid requirements
timeFrame: 30 days post hospital admission (or previously at hospital discharge)
measure: Transfusion requirements
timeFrame: 24 hours (or previously at discharge of the emergency room)
measure: Transfusion requirements
timeFrame: 30 days post hospital admission (or previously at hospital discharge)
measure: Water balance
timeFrame: 24 hours of admission at the ICU
measure: Water balance
timeFrame: 72 hours of admission at the ICU
measure: Ventilator-free days
timeFrame: 30 days
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Josep Trueta
Study officials:
References: