TXA in the EMS on the Helicopter and the Ambulance

Phase 4

• Conditions: Bleeding
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT02354885
• Lead Sponsor: University of Zurich

Brief 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.

Study Timeline

• Study Start: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-29
• Last Update Submitted: 2015-01-29
• Study First Posted: 2015-02-03
• Last Update Posted: 2015-02-03
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• multiple trauma
• traumatic brain injury

Exclusion Criteria

• pregnant
• < 18 years
• no TXA
• not speaking the german language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid	TXA administered to multiple trauma patients in the helicopter or ambulance

Primary Outcome Measures

Name	Time	Method
Tranexamic acid administered in the preclinical setting and its influence on coagulation parameters (laboratory and thromboelastometry)	12 Months	TXA will be given to multiple trauma patients or patients with isolated TBI in the preclinical setting (n=50). Before tranexamic acid is given, one tube of citrated blood is drawn. Once patients arrive in the emergency room as second tube of citrated blood is drawn. The two tubes will be used to perform rotational thromboelastometry (ROTEM) measurements and standard coagulation measurements (aPTT, PT, INR, Ouick's value, fibrinogen). The coagulation parameters on scene will be compared to those in the emergency department to find out if coagulation is improved by this. In a previously performed study, 50 patients got blood taken on scene and in the emergency room without receiving TXA. In this study by Theusinger et al. it was shown that coagulation is impaired during this time period.(Theusinger OM et al. Anesth Analg. 2014 Dec 24.PMID: 25545751). The population of this study will serve as control group for the actually performed study.

Trial Locations

Locations (2)

University Hospital Zurich, Division of Anaesthesiology; 🇨🇭 Zurich, ZH, Switzerland

USZ; 🇨🇭 Zurich, Switzerland