Traumatic Hemorrhage Clinical Trial
Official title:
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial For Trauma Patients At Risk Of Hemorrhage (STAAMP Trial); Phase III Multicenter, Prospective, Randomized, Double Blind, Interventional Trial
The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given during emergency medical transport to a level 1 trauma center in patients at risk of hemorrhage is associated with lower 30 day mortality.
Background: Traumatically injured patients continue to be plagued with uncontrolled
hemorrhage resulting in significant morbidity and early mortality. A primary driving force
for this unbridled hemorrhage is known to be the early coagulopathy which complicates severe
injury. Trauma induced coagulopathy has been postulated to be an equilibrium imbalance
between pro and anticoagulant factors, platelets, endothelium and fibrinolysis soon after
injury. Recent evidence demonstrates that the early use of the antifibrinolytic agent
tranexamic acid (TXA) after trauma center arrival results in improved survival in patients at
risk for bleeding. Bringing this proven treatment to the prehospital arena and intervening
earlier in those patients who would otherwise not be candidates for treatment has the real
potential to further reduce or prevent the vicious hemorrhagic cascade, improve clinical
outcomes and provide insight into the underlying mechanisms responsible for and which
maximize its benefit.
Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of tranexamic
acid in patients at risk for bleeding will reduce the incidence of 30 day mortality. The
secondary hypotheses include that prehospital tranexamic acid will reduce the incidence of
hyperfibrinolysis, acute lung injury, multiple organ failure, nosocomial infection,
mortality, early seizures, pulmonary embolism and early resuscitation needs, reduce or
prevent the early coagulopathy as demonstrated by improving presenting INR and rapid
thromboelastography parameters, reduce the early inflammatory response, plasmin levels,
leukocyte, platelet and complement activation, and determine the optimal dosing of tranexamic
acid post-injury.
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