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

University of Zurich (UZH)

Status and phase: Unknown; Phase 4

Conditions: Bleeding

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02354885

KEK-ZH-Nr. 2014-0069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• multiple trauma
• traumatic brain injury

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Tranexamic Acid

No Intervention group

Description:

TXA administered to multiple trauma patients in the helicopter or ambulance

Treatment:

Drug: Tranexamic Acid