NCT02354885

TXA in the EMS on the Helicopter and the Ambulance

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).

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bleeding

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Coagulation Management / Efficiency

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-02-03
• Last updated: 2015-02-03

Locations

2 sites across 1 country: Switzerland