- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02354885
TXA in the EMS on the Helicopter and the Ambulance (TXASRZREGA)
January 29, 2015 updated by: Oliver Theusinger, University of Zurich
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).
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oliver M Theusinger, PD Dr med
- Email: oliver.theusinger@usz.ch
Study Locations
-
-
-
Zurich, Switzerland, 8091
- Recruiting
- USZ
-
Contact:
- Oliver M Theusinger, PD Dr med
- Phone Number: +41442552710
- Email: oliver.theusinger@usz.ch
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- Recruiting
- University Hospital Zurich, Division of Anaesthesiology
-
Contact:
- Oliver M Theusinger, PD Dr med
- Email: oliver.theusinger@usz.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- multiple trauma
- traumatic brain injury
Exclusion Criteria:
- pregnant
- < 18 years
- no TXA
- not speaking the german language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Tranexamic Acid
TXA administered to multiple trauma patients in the helicopter or ambulance
|
Coagulation Management / Efficiency
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oliver M. Theusinger, PD Dr med, USZ
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
January 16, 2015
First Submitted That Met QC Criteria
January 29, 2015
First Posted (Estimate)
February 3, 2015
Study Record Updates
Last Update Posted (Estimate)
February 3, 2015
Last Update Submitted That Met QC Criteria
January 29, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr. 2014-0069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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