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TXA in the EMS on the Helicopter and the Ambulance — TXASRZREGA  

Bleeding Clinical Trial

Official title:
Administration of Tranexamic Acid in the Preclinical Setting and Its Effect on Coagulation Parameters and Outcome in Multiple Trauma Patients and Isolated TBI in EMS (Schutz Und Rettung Zürich) and Helicopter Rescue(REGA).

Clinical Trial Summary

Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic acid (TXA) seems to improve survival and outcome. Thus this study evaluates the administration of TXA on scene by the emergency medical services (EMS) or by the crew of a rescue helicopter in multiple trauma patients or isolated traumatic brain injury (TBI). Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry.

Clinical Trial Description

Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic acid (TXA) seems to improve survival and outcome; this was shown partially by the CRASH2 study, where patients received TXA in the emergency room. Thus this study evaluates the administration of TXA on scene by the EMS or by the crew of a rescue helicopter in multiple trauma patients or isolated TBI. Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry in 50 patients. The results will be compared to a study published by Theusinger et al. (Changes in Coagulation in Standard Laboratory Tests and ROTEM in Trauma Patients Between On-Scene and Arrival in the Emergency Department.Theusinger OM et al. Anesth Analg. 2014 Dec 24. [Epub ahead of print] PMID: 25545751) where no TXA was administered on scene and only changes in coagulation between on scene and in the emergency department were assessed. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02354885
Study type Interventional
Source University of Zurich
Contact Oliver M Theusinger, PD Dr med
Email oliver.theusinger@usz.ch
Status Recruiting
Phase Phase 4
Start date December 2014
Completion date December 2015
View Details
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