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TXA in the EMS on the Helicopter and the Ambulance (TXASRZREGA)

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ClinicalTrials.gov Identifier: NCT02354885
Recruitment Status : Unknown
Verified January 2015 by Oliver Theusinger, University of Zurich.
Recruitment status was:  Recruiting
First Posted : February 3, 2015
Last Update Posted : February 3, 2015
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
Luzerner Kantonsspital
Information provided by (Responsible Party):
Oliver Theusinger, 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.

Condition or disease Intervention/treatment Phase
Bleeding Drug: Tranexamic Acid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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).
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Tranexamic Acid
TXA administered to multiple trauma patients in the helicopter or ambulance
Drug: Tranexamic Acid
Coagulation Management / Efficiency
Other Name: ROTEM




Primary Outcome Measures :
  1. Tranexamic acid administered in the preclinical setting and its influence on coagulation parameters (laboratory and thromboelastometry) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • multiple trauma
  • traumatic brain injury

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354885


Contacts
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Contact: Oliver M Theusinger, PD Dr med oliver.theusinger@usz.ch

Locations
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Switzerland
University Hospital Zurich, Division of Anaesthesiology Recruiting
Zurich, ZH, Switzerland, 8091
Contact: Oliver M Theusinger, PD Dr med       oliver.theusinger@usz.ch   
USZ Recruiting
Zurich, Switzerland, 8091
Contact: Oliver M Theusinger, PD Dr med    +41442552710    oliver.theusinger@usz.ch   
Sponsors and Collaborators
University of Zurich
Cantonal Hospital of St. Gallen
Luzerner Kantonsspital
Investigators
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Principal Investigator: Oliver M. Theusinger, PD Dr med USZ

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oliver Theusinger, PD Dr med, University of Zurich
ClinicalTrials.gov Identifier: NCT02354885     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2014-0069
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants