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Early Trauma Induced CoagulopathyeTICNCT07186712

The Incidence of Early Trauma Induced Coagulopathy and Hyperfibrinolysis in Severely Injured Trauma Patients in the Emergency Room: a Retrospective Cohort Study

An observational study of Early Trauma Induced Coagulopathy and Tic, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to quantify the incidence of eTIC (defined as an elevated appt) and hyperfibrinolysis (defined as Ly30>7) in early trauma patients. To identify patients at risk of eTIC and hyperfibrinolysis, we will conduct a systematic search for trauma patients with an ISS>16 in whom a thrombelastogram… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early Trauma Induced Coagulopathy, Tic
How many people
263 participants
Where
1 siteAustria
Study dates
25 May 2025to 20 Oct 2025
Phase
Observational
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

Study population: patients with severe trauma (ISS>16)

Who may be able to join

  • Age < 18 years
  • Sever trauma (ISS>16)
  • Coagulation parameters (PT, aPTT, INR, fibrinogen, TEG) available within the first hour of admission

Who cannot join

  • Patients with known pre-existing coagulopathies
  • Patients on anticoagulant therapy prior to trauma
  • Incomplete or missing coagulation data

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Medical University of Graz

    Graz, 8043

Other trials in Austria

About this study

The aim of this study is to quantify the incidence of eTIC (defined as an elevated appt) and hyperfibrinolysis (defined as Ly30>7) in early trauma patients. To identify patients at risk of eTIC and hyperfibrinolysis, we will conduct a systematic search for trauma patients with an ISS>16 in whom a thrombelastogram (TEG) was obtained in the emergency department (ED)

Read the detailed description

Despite excessive efforts to reduce the number of preventable deaths in patients suffering from traumatic injuries, hemorrhage is still a leading cause of morbidity and mortality in this patient group. (1) The importance of trauma induced coagulopathy (TIC) on the extent of blood loss has been known at least since 1982. Where Kashuk et al. described the lethal triad of hypothermia, acidosis and coagulopathy for trauma patients. (2) In 2003 two landmark studies firstly identified that coagulopathy was present in the early phase after patients suffered severe traumatic injuries and prior to resuscitation efforts. In both studies the rate of early trauma induced coagulopathy (eTIC) was high (24.4% Brohi et al., 28% Macleod et al.), even in patients with relatively low median injury severity scores (mean ISS 20 and 9). Notably, both studies identified eTIC as an independent predictor of mortality. (3) (4) Nowadays, health care providers and guidelines heavily emphasis the importance of eTIC in trauma resuscitation. However, in a cohort study from Teeter et al. published in 2024 with the data of two major trauma centers in the US found that the incidence of eTIC (defined as the initial prothrombin time (PT) or partial thromboplastin time (PTT) above normal per each center's reference range) increased to 33.4% and that coagulopathy had a major impact on mortality over all severity ranges. (5) However, to detect trauma induced coagulopathy new technologies such as thrombelastography (TEG) and rotational thromboelastometry (ROTEM) have been implemented in the trauma algorithm of major trauma centers since 2003. These tests offer a rapid, comprehensive assessment of the dynamic and sequential processes involved in trauma-induced coagulopathy. (6) With the opportunity of early detection of different entities of eTIC including Hyperfibrinolysis, Thromelastography has shown to corresponded to a reduction in hospital length of stay, intensive care unit length of stay and cost of transfused blood products. (6)

  1. Study objective 2.1 Primary Aim The aim of this study is to quantify the incidence of eTIC (defined as an elevated appt) and hyperfibrinolysis (defined as Ly30>7) in early trauma patients. To identify patients at risk of eTIC and hyperfibrinolysis, we will conduct a systematic search for trauma patients with an ISS>16 in whom a thrombelastogram (TEG) was obtained in the emergency department (ED)

The primary values of interest are:

  • Initial activated partial thrombin time (appt)
  • INR
  • TEG (R time, MA, Lyseindex 30)

2.2 Secondary objectives

  • Correlation of standard laboratory abnormalities (defined as an elevated appt) and TEG findings
  • Correlation of eTIC and mortality
  • Correlation of eTIC and blood product use in the first 24h
Keywords
eTIC, coagulopathy, trauma
Medical subject headings
Tics, Hemostatic Disorders, Wounds and Injuries

What participants receive

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

Study groups in NCT07186712
Study groupRoleWhat they receive
Patients in the trauma resuscitation bay of the Medical University of GrazValid thrombelastogramm available

What is being measured

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

  1. incidence of eTIC

    defined by increased appt/INR

    Measured: 1 hour after admission

Secondary outcomes (3)
  1. incidence of hyperfibrinolysis

    defined as Ly30>7

    Measured: 1 hour after admission

  2. Correlation of standard laboratory abnormalities and TEG findings

    R and appt/INR MA and appt/INR K and appt/INR

    Measured: 1 hour after admission

  3. Correlation of eTIC and mortality

    eTIC defined by an increase of appt/INR

    Measured: 30 days

Timeline

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

  1. First posted22 Sep 2025
  2. Study start25 May 2025
  3. Primary completion15 Sep 2025
  4. Study completion20 Oct 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07186712
Sponsor's protocol ID
1150/2025
Acronym
eTIC
Status last verified
Jan 2026
First submitted
15 Sep 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Honnef G, Zoidl P, Hallmann B, Missmann M, Eichinger M, Niederer M, Zajic P. Prognostic Value of Thromboelastography Parameters for Early Trauma-Induced Coagulopathy in Severely Injured Patients: A Retrospective Cohort Study. Acad Emerg Med. 2026 Oct;33(10):e70423. doi: 10.1111/acem.70423.

    PubMed 42902959

Questions about this trial

What is this clinical trial studying?

An observational study of Early Trauma Induced Coagulopathy and Tic, run by Medical University of Graz at 1 site in Austria.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of eTIC (time frame: 1 hour after admission). 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 NCT07186712, 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 28 Jan 2026.

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