Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy

Launched by HOSPICES CIVILS DE LYON · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different types of tests used to diagnose and manage a serious condition called trauma-induced coagulopathy, which can occur after severe injuries. The trial compares conventional coagulation tests (CCTs), which take over an hour to provide results, to viscoelastic tests (VETs), which give results in about 10 minutes. The goal is to see if using VETs can improve patient outcomes, such as reducing the need for blood transfusions and improving survival rates after trauma.

To participate in this trial, individuals must be 18 years or older and have suffered a severe injury within the last three hours. They should also show signs of shock or anemia, or have specific types of serious injuries, such as fractures. If enrolled, participants can expect to receive either type of test to help guide their treatment in the emergency setting. This study is important because it aims to find out if faster testing can lead to better care for patients with serious injuries who are at risk of coagulopathy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older
• • Blunt or penetrating injury
• • Less than 3 hours after a trauma AND less than 1 hour after trauma room admission
• * One of the following criteria:
• * Severe trauma in shock (shock index \> 0.9 or SBP \< 90 mmHg) or with anemia (hemoglobin \< 11 g.dL-1) and at least 1 of the following criteria:
• • Positive extended-FAST (Focused Assessment with Sonography for Trauma, ultrasound) finding liquid
• * Severe bone injury :
• • Fracture of at least two long bones
• • Amputation above the knee or elbow
• • Open fracture of the pelvis and/or mechanically unstable pelvis
• • Severe trauma with a high probability of having a TIC (PTratio \> 1.20) according to the TIC score (score value ≥ 6 - cf. appendix 2)
• • Emergency procedure with secondary informed consent signed by the patient
• Exclusion Criteria:
• • Known pregnancy at admission
• • Transfer from another hospital
• • Cardiac arrest before randomization
• • Patient with devastating injuries expected to die within the first hour post-admission
• • Massive head injury with GCS 3 and bilateral mydriasis
• • Pre-hospital transfusion of RBCs unit or coagulation factors concentrates
• • No tranexamic acid before hospital admission
• • Patient with uncontrolled major bleeding on arrival with direct admission to the operating room for rescue surgery
• • Conventional or viscoelastic assay before inclusion/randomization
• • Hypothermia \< 33°C
• • Known use of oral anticoagulants (VKA or DOACs)
• • Known congenital hemostasis abnormality
• • Predictable transfer to another hospital \<12 hours after admission
• • Patients protected by articles L1121-6 and L1121-7 of the Public Health Code, adults subject to legal protection measures
• • Patient not affiliated to a social security scheme
• • Patient included in other interventional study on coagulopathy.