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BleedingPhase 4TXASRZREGANCT02354885

TXA in the EMS on the Helicopter and the Ambulance

A Phase 4 study testing Tranexamic Acid in people with Bleeding, run by University of Zurich at 2 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bleeding
What is being tested?
Tranexamic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesSwitzerland
Study dates
Dec 2014to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • multiple trauma
  • traumatic brain injury

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Oliver M Theusinger, PD Dr med contact

oliver.theusinger@usz.ch

Switzerland2 sites, 2 recruiting

  • University Hospital Zurich, Division of Anaesthesiology

    Zurich, Canton of Zurich, 8091

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

    Recruiting

  • USZ

    Zurich, 8091

    Oliver M Theusinger, PD Dr med, +41442552710, oliver.theusinger@usz.ch

    Recruiting

Other trials in Switzerland

About this study

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).

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.

Read the 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
Being tested
Tranexamic Acid
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02354885
Study groupRoleWhat they receive
Tranexamic AcidNo interventionTXA administered to multiple trauma patients in the helicopter or ambulance
Receives: Drug: Tranexamic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02354885
Sponsor's protocol ID
KEK-ZH-Nr. 2014-0069
Acronym
TXASRZREGA
Status last verified
Jan 2015
First submitted
16 Jan 2015
Last updated
3 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29239953

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic Acid in people with Bleeding, run by University of Zurich at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oliver M Theusinger, PD Dr med (oliver.theusinger@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tranexamic acid administered in the preclinical setting and its influence on coagulation parameters (laboratory and thromboelastometry) (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02354885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.

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