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

NCT ID: NCT07186712

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 263 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-25
• Study Completion Date: 2025-10-20

Brief 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)

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

Conditions

Early Trauma Induced Coagulopathy; Tic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Valid thrombelastogramm available

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

1150/2025

Identifier Type: -

Identifier Source: org_study_id