None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Tranexamic Acid in a loading dose of 1 g in 100 ml of 0.9% Sodium Chloride, IV in 10 minutes, followed by the administration of Tranexamic Acid, at a dose of 120 mg / hour, in IV infusion to a speed of 60 ml / hour for about 8 hours.
Group name:GROUP 2 Type of group
This group will be treated with Placebo of Tranexamic Acid in bolus in 100 ml of 0.9% Sodium Chloride, IV in 10 minutes, followed by administration of Placebo of Tranexamic Acid, in IV infusion at a rate of 60 ml / hour for approximately 8 hours .
Sponsors
LONDON SCHOOL OF HYGIENE & TROPICAL MEDICINE,
Eligibility
Inclusion criteria
Inclusion criteria: All patients with significant trauma and bleeding (systolic pressure less than 90 mmHg and / or heart rate greater than 110 per minute), or those who are considered to be at risk of significant bleeding and are within 8 hours are eligible for the study. of the injury if they appear to be at least 16 years old. Although patients can be admitted up to 8 hours after the injury, the sooner the patient can be treated, the better.
Exclusion criteria
Exclusion criteria: The fundamental criterion of eligibility is the uncertainty of the responsible physician on whether or not to use an antifibrinolytic agent in a specific adult with traumatic hemorrhage. Patients in whom the responsible physician considers that there is a clear indication for the use of antifibrinolytic therapy should not be randomized. Likewise, patients in whom it is considered that there is a clear contraindication of antifibrinolytic therapy should not be randomized. All patients in whom the responsible physician is substantially undecided whether or not to use an antifibrinolytic agent are eligible for randomization. There are no other pre-specified exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation in which it will be determined if the death was due to hemorrhage or vascular occlusion. Measure:In-hospital death within four weeks of the injury. Timepoints:When the event is presented. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation that will determine the reception of blood transfusion products received, number of units of transfused blood products, of surgical interventions performed and number of thromboembolic episodes. Measure:1) Reception of blood transfusion products received. 2) Number of units of blood products transfused. 3) Number of surgical interventions performed. 4) Number of thromboembolic episodes. Timepoints:When the event is presented. | — |
Countries
Albania, Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Colombia, Cuba, Czech Republic, Ecuador, Egypt, El Salvador, Georgia, Ghana, India, Indonesia, Iran, Iraq, Italy, Jamaica, Japan, Kenya, Malasya, Mexico, Niger, Poland, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Tanzania, Thailand, Tunisia, United Kindgdom, Zambia
Contacts
Public ContactJ. Jaime Miranda
DR. JAIME MIRANDA MONTERO
Outcome results
None listed