TXA in the EMS on the Helicopter and the Ambulance

Bleeding Clinical Trial

— TXASRZREGA  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02354885
• Other study ID #: KEK-ZH-Nr. 2014-0069
• Status: Recruiting
• Phase: Phase 4
• First received: January 16, 2015
• Last updated: January 29, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: University of Zurich
• Contact: Oliver M Theusinger, PD Dr med
• Email: oliver.theusinger[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Cantonal Office of Public Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• multiple trauma

• traumatic brain injury

Exclusion Criteria:

• pregnant

• < 18 years

• no TXA

• not speaking the german language

Study Design

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

Related Conditions & MeSH terms

• Bleeding

Intervention

Drug:
• Tranexamic Acid
Coagulation Management / Efficiency

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Anaesthesiology	Zurich	ZH
Switzerland	USZ	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Cantonal Hospital of St. Gallen, Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tranexamic acid administered in the preclinical setting and its influence on coagulation parameters (laboratory and thromboelastometry)	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.	12 Months	No