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.
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.
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)
- 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
- Conditions
- Early Trauma Induced Coagulopathy, Tic
- 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 group | Role | What they receive |
|---|---|---|
| Patients in the trauma resuscitation bay of the Medical University of Graz | Valid thrombelastogramm available |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of eTIC
defined by increased appt/INR
Measured: 1 hour after admission
Secondary outcomes (3)
incidence of hyperfibrinolysis
defined as Ly30>7
Measured: 1 hour after admission
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
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.
- First posted22 Sep 2025
- Study start25 May 2025
- Primary completion15 Sep 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Trauma Induced CoagulopathyStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Early Trauma Induced Coagulopathy and Hyperfibrinolysis in Severely Injured Trauma Patients in the Emergency Room: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07186712
- Acronym / sponsor ID
- eTIC / 1150/2025
- Conditions
- Early Trauma Induced Coagulopathy, Tic
- Keywords
- eTIC, coagulopathy, trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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)
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in the trauma resuscitation bay of the Medical University of Graz | – | –Valid thrombelastogramm available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe trauma (ISS>16)
Key inclusion criteria (3 listed)
- Age < 18 years
- Sever trauma (ISS>16)
- Coagulation parameters (PT, aPTT, INR, fibrinogen, TEG) available within the first hour of admission
Key exclusion criteria (3 listed)
- Patients with known pre-existing coagulopathies
- Patients on anticoagulant therapy prior to trauma
- Incomplete or missing coagulation data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of eTIC
Time frame: 1 hour after admission
defined by increased appt/INR
3 secondary outcomes
incidence of hyperfibrinolysis
Time frame: 1 hour after admission
Correlation of standard laboratory abnormalities and TEG findings
Time frame: 1 hour after admission
Correlation of eTIC and mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 42902959Honnef 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.