TXA in the EMS on the Helicopter and the Ambulance

NCT ID: NCT02354885

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Tranexamic Acid

TXA administered to multiple trauma patients in the helicopter or ambulance

Group Type: NO_INTERVENTION

Tranexamic Acid

Intervention Type: DRUG

Coagulation Management / Efficiency

Interventions

Tranexamic Acid

Coagulation Management / Efficiency

Intervention Type: DRUG

Other Intervention Names

ROTEM

Eligibility Criteria

Inclusion Criteria

• multiple trauma
• traumatic brain injury

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Oliver Theusinger

PD Dr med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver M. Theusinger, PD Dr med

Role: PRINCIPAL_INVESTIGATOR

USZ

Locations

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

USZ

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Oliver M Theusinger, PD Dr med

Role: CONTACT

oliver.theusinger@usz.ch

Facility Contacts

Oliver M Theusinger, PD Dr med

Role: primary

oliver.theusinger@usz.ch

Oliver M Theusinger, PD Dr med

Role: primary

oliver.theusinger@usz.ch

+41442552710

References

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.

Reference Type: DERIVED

PMID: 29239953 (View on PubMed)

Other Identifiers

KEK-ZH-Nr. 2014-0069

Identifier Type: -

Identifier Source: org_study_id