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CompletedNCT07186712eTICUpdated Jan 28, 2026

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 in Early Trauma Induced Coagulopathy and Tic, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
263
Ages
18 Years and older
Sex
All
01

Study 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 (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)

2. 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
02

Conditions studied

  • Early Trauma Induced Coagulopathy
  • Tic

Keywords

  • eTIC
  • coagulopathy
  • trauma
03

In context

Tics

65 studies on the registry are indexed under Tics; 11 are open to participants now.

This study's enrollment of 263 is above the median of 45 across 12 observational studies indexed under Tics.

Browse Tics studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with severe trauma (ISS>16)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with known pre-existing coagulopathies
  • Patients on anticoagulant therapy prior to trauma
  • Incomplete or missing coagulation data
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
263 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients in the trauma resuscitation bay of the Medical University of Graz

    Valid thrombelastogramm available

06

What researchers measure

Primary outcomes

  1. incidence of eTIC

    defined by increased appt/INR

    Time frame: 1 hour after admission

Secondary outcomes

  1. incidence of hyperfibrinolysis

    defined as Ly30\>7

    Time frame: 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

    Time frame: 1 hour after admission

  3. Correlation of eTIC and mortality

    eTIC defined by an increase of appt/INR

    Time frame: 30 days

07

Study locations

1 site
  • Medical University of Graz
    Graz, 8043, Austria
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2025 to primary completion in Sep 2025, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2025
First posted
Sep 22, 2025
StartActual
May 25, 2025
Primary completionActual
Sep 15, 2025
CompletionActual
Oct 20, 2025
Last update
Jan 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07186712
Responsible party
Sponsor
First posted
Sep 22, 2025
Start date
May 25, 2025
Primary completion
Sep 15, 2025
Completion
Oct 20, 2025
Last update
Jan 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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