TXA in the EMS on the Helicopter and the Ambulance

NCT02354885 | Unknown Phase 4

• 1 other identifier: KEK-ZH-Nr. 2014-0069
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Tranexamic Acid

NO INTERVENTION

TXA administered to multiple trauma patients in the helicopter or ambulance

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Coagulation Management / Efficiency

Also known as: ROTEM

Tranexamic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• multiple trauma
• traumatic brain injury

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead
• Cantonal Hospital of St. Gallen: collaborator
• Luzerner Kantonsspital: collaborator

Study Sites (2)

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

USZ

Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

• Stein P, Studt JD, Albrecht R, Muller S, von Ow D, Fischer S, Seifert B, Mariotti S, Spahn DR, Theusinger OM. The Impact of Prehospital Tranexamic Acid on Blood Coagulation in Trauma Patients. Anesth Analg. 2018 Feb;126(2):522-529. doi: 10.1213/ANE.0000000000002708.

  PMID: 29239953 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Oliver M. Theusinger, PD Dr med

  USZ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver M Theusinger, PD Dr med

CONTACT

oliver.theusinger@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr med

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 3, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 3, 2015

Record last verified: 2015-01

Locations

CH (2)