The purpose of this research is to determine whether giving severely injured adults a drug called tranexamic acid (TXA) as soon as possible after injury will improve their chances of survival and their level of recovery at six months. After severe injury, a person may have uncontrolled bleeding that places them at high risk of bleeding to death. Coagulation (the formation of blood clots) is an important process in the body that helps to control blood loss. Up to a quarter of people that are severely injured have a condition called acute traumatic coagulopathy. This condition affects coagulation and results in the break down of blood clots (fibrinolysis) that can lead to increased blood loss and an increased risk of dying. TXA is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic coagulopathy by preventing blood clots from breaking down and helping to control bleeding. In Australia, TXA is approved for use by the Therapeutic Goods Administration (TGA) to reduce blood loss or the need for blood transfusion in patients undergoing surgery (i.e. cardiac surgery, knee or hip arthroplasty). Recent evidence from a large clinical trial (CRASH-2) showed early treatment with TXA reduced the risk of death in severely injured patients, however the majority of patients involved in the study were injured in countries where prehospital care is limited and rapid access to lifesaving treatments is limited compared to that available in countries like Australia and New Zealand. It is unclear whether TXA will reduce the risk of death to the same degree when it is given alongside other lifesaving treatments that are available to patients soon after injury in these countries. The hypothesis is that TXA given early to injured patients who are at risk of acute traumatic coagulopathy and who are treated in countries with systems providing advanced trauma care reduces mortality and improves recovery at 6-months after injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,310
Tranexamic acid is a synthetic lysine derivative that inhibits fibrinolysis by blocking the lysine binding sites on plasminogen therefore inhibiting the conversion of plasminogen to plasmin. Intravenous injection of 1g Tranexamic Acid will be administered in the pre-hospital setting followed by 1g Tranexamic Acid infused intravenously over 8 hours initiated in the hospital emergency department.
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The proportion of patients with a favourable outcome (moderate disability or good recovery, GOSE scores 5-8) compared to those who have died (GOSE 1), or have severe disability (GOSE 2-4).
Time frame: 6 months
Units of blood products used (red blood cells, plasma, platelets, prothrombin complex concentrate, fibrinogen, Factor VIIa, cryoprecipitate)
Time frame: 24 hours
Coagulation assessed using the international normalised ratio (INR)
Time frame: Immediately upon patient arrival to hospital
Coagulation assessed using the international normalised ratio (INR)
Time frame: At the end of 8 hour infusion of study drug
Coagulation assessed using the international normalised ratio (INR)
Time frame: 24 hours after pre-hospital dose of study drug
Coagulation assessed by activated partial thromboplastin time (APTT)
Time frame: Immediately upon patient arrival to hospital
Coagulation assessed by activated partial thromboplastin time (APTT)
Time frame: At the end of 8 hour infusion of study drug
Coagulation assessed by activated partial thromboplastin time (APTT)
Time frame: 24 hours after pre-hospital dose of study drug
Platelet count
Time frame: Immediately upon patient arrival to hospital
Platelet count
Time frame: At the end of 8 hour infusion of study drug
Platelet count
Time frame: 24 hours after pre-hospital dose of study drug
Vascular occlusive events (myocardial infarction, stroke, deep venous thrombosis (DVT), pulmonary embolus (PE))
Time frame: Hospital discharge (or up to 28 days in hospital)
Ventilator-free days
Time frame: 28 days
Mortality
Time frame: 24 hours
Mortality
Time frame: 28 days
Mortality
Time frame: 6 months
Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
Time frame: 24 hours
Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
Time frame: 28 days
Proportion of deaths due to bleeding, vascular occlusion (pulmonary embolus, stroke, acute myocardial infarction), multi-organ failure, or head injury
Time frame: 6 months
Cumulative incidence of sepsis
Time frame: Hospital discharge (or up to 28 days in hospital)
Quality of life measured using WHODAS 2.0
Time frame: 6 months
Quality of life measured using the EuroQOL 5 dimensions questionnaire (EQ-5D)
Time frame: 6 months
Number of participants with serious adverse events
Time frame: hospital discharge (or up to 28 days in hospital)
Coagulation assessed by fibrinogen
Time frame: Immediately upon patient arrival to hospital
Coagulation assessed by fibrinogen
Time frame: At the end of 8 hour infusion of study drug
Coagulation assessed by fibrinogen
Time frame: 24 hours after pre-hospital dose of study drug
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