Trauma CoagulopathyVISCOTACNCT06820879
Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy
A study testing Viscoelastic Tests (ROTEM) in people with Trauma Coagulopathy, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
Traumatic coagulopathy is a complex, multifactorial event that occurs in 20-30% of patients on admission. It increases mortality, and its treatment is one of the main priorities in the early management of severely injured patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Coagulopathy
- What is being tested?
- Viscoelastic Tests (ROTEM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Oct 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laurent VILLENEUVE contact
7 sites in 1 country
France7 sites
Service d'Anesthésie - Réanimation, CHU Angers
Angers, 49933
Guillaume BOUHOURS, GuBouhours@chu-angers.fr
Guillaume BOUHOURS
Service d'Anesthésie - Réanimation, Groupe Hospitalier Pellegrin CHU de Bordeaux
Bordeaux, 33000
Barbara BLONDEAU, barbara.blondeau@chu-bordeaux.fr
Barbara BLONDEAU
Service de Réanimation - CH Annecy Genevois
Epagny METZ Tessy, 74374
Service d'Anesthésie - Réanimation, Hôpital Michallon- CHU Grenoble
La Tronche, 38700
Pierre BOUZAT, PBouzat@chu-grenoble.fr
Pierre BOUZAT
Service d'Anesthésie - Réanimation, HCL Edouard Herriot
Lyon, 69003
Anne Claire LUKASZEWICZ, anne-claire.lukaszewicz@chu-lyon.fr
Anne-Claire LUKASZEWICZ
Service d'Anesthésie-Réanimation, HCL Lyon Sud
Pierre-Benité, 69495
Jean-Stéphane, jean-stephane.david@chu-lyon.fr
Jean Stéphane DAVID
Service d'Anesthésie - Réanimation, HIA St Anne Toulon
Toulon, 83000
Julien BORDES, julien.bordes@intradef.gouv.fr
Julien BORDES
About this study
Official title: Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy: Opened, Randomized, Two-Parallel, Controlled Trial.VISCOTAC
Traumatic coagulopathy is a complex, multifactorial event that occurs in 20-30% of patients on admission. It increases mortality, and its treatment is one of the main priorities in the early management of severely injured patients. Diagnosis of coagulopathy has traditionally been based on conventional coagulation tests (CCTs), which provide an assessment of patients' coagulation in over 60 minutes. Over the past fifteen years, viscoelastic tests (VETs) have been proposed, providing a more rapid result (≤ 10 min) and can guide the administration of labile blood products (LBP). Various studies, mainly retrospective, have shown that the use of VETs is associated with a significant reduction in the use of LBP and the incidence of massive transfusions (MT).
For example, it has been showed that the use of VETs was accompanied by a reduction in the administration of LBP and more particularly of RBC (Red blood cell concentrate) (4.8 units vs. 1.9 units). The investigators obtained the same result on a larger number of patients, with a further reduction in the administration of other LBP and in the incidence of MT (33% vs. 8%, p<0.01).
Read more
However, the main limitation of these 2 studies is that the results may not have been due solely to the use of ROTEM, but rather to a care package combining the use of ROTEM with the administration of tranexamic acid and the implementation of Damage Control Surgery techniques.
To avoid this methodological criticism, we recently compared 2 contemporary French cohorts (2012-2019), in which patients had similar management of traumatic injuries, with the exception of the type of coagulation tests: CCT vs. VET. The use of VET s was associated with an increase in the number of patients alive at 24h without MT (76% vs. 55%, p<0.001), but also with a sharp reduction in the administration of all LBPs.
This composite criterion associating the occurrence of a MT with survival at 24 hours after hospital admission was the primary endpoint of the randomized iTACTIC study. iTACTICS was published in 2021, and aimed to compare in severely injured patients 2 strategies for the diagnosis and treatment of coagulopathies, based on CCT in one arm and VET in the other. In this work, the use of VET was not associated with an improvement in the proportion of patients alive at 24 hours without MT (64% vs. 67%, OR 1.15, CI95%: 0.8-1.7), nor with any of the other criteria studied. The main limitation of this study is that less than a third of the patients included had a coagulopathy on admission. The probability of receiving LBP was therefore low. In the subgroup of the most severe patients, an improvement in the primary endpoint was observed for patients randomized to the VET group. The small sample size and subgroup analysis, however, limited the significance of this result.
All these elements suggest that it is necessary :
- to use a composite endpoint rather than a single endpoint (mortality) for the evaluation of VET-based strategies, combining early mortality with the occurrence of a transfusion event.
- conduct a randomized trial comparing the use of VETs with that of CCTs in trauma patients with a high probability of coagulopathy on admission to hospital.
- Conditions
- Trauma Coagulopathy
- Being tested
- Viscoelastic Tests (ROTEM)
- Keywords
- Coagulopathy, coagulation tests, viscoelastic tests, massives transfusions, labile blood products
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscoelastic Tests (ROTEM)Device
Viscoelastic Tests (2-6 tests for the study over the first 24 hours)
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm: conventional coagulation tests. | No intervention | In this arm, patients will have a detection and a correction of the TIC based on conventional coagulation assays. The threshold used to initiate a correction, in case of ongoing bleeding, will be set at fibrinogen concentration ≤ 1.5 gr/L, PTratio >1.5 or platelets < 50 G.L-1 (< 100 G.L-1 in case of severe brain injury). |
| Viscoelastic arm: Viscoelastic Tests | Experimental | The detection and correction of TIC will be based on viscoelastic assay using values of clotting time (CT EXTEM), clot amplitude at 5 minutes (A5 FIBTEM and A5 EXTEM) and maximum lysis (ML). The algorithm for the study has been recently published and is based on thresholds for EXTEM (CT, A5 and ML), FIBTEM (A5). The algorithmic correction by fibrinogen concentrates and FFP is initiated using different cutoffs and parameters than in control arm, but the quantity of fibrinogen concentrates and FFP transfused will be similar in both arms. Receives: Device: Viscoelastic Tests (ROTEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival without massive transfusion 24 hours after admission in the VET arm as compared to the CCT arm.
24 hours after admission in the VET arm as compared to the CCT arm. The survival 24 hours after admission will be combine with the non-occurrence of massive transfusion (i.e., at least 10 units of RBC received at 24h).
This comparison will be first carried out in a crude manner, and then considering the stratification factor, i.e., a Glasgow Coma Scale < 9 (severe traumatic brain injury) and administration of plasma (FFP or lyophilized plasma).
Measured: 24hours after admission
Secondary outcomes (11)
Number and proportion of patient receiving labile blood products, at 4, 6 and 24 hours after hospital admission.
Measured: 4, 6 and 24 hours after hospital admission
Number and proportion of patients receiving fibrinogen concentrates as well as the quantity administered (in grams), at 6 and 24 hours after hospital admission
Measured: 6 and 24 hours after hospital admission
Number and proportion of patients who received massive transfusion, time critical transfusion and Rescue therapy
- A massive transfusion (MT, ≥ 10 RBC at H24)
- A time critical transfusion (≥ 6 RBC at H6 following the admission).
- Rescue therapy, defined as the emergency administration of blood products because the patient's clinical condition makes it impossible to wait for the results of biological tests (CCT or VTE).
Measured: 24 hours
Number of RBCs received from admission to ICU discharge (or at 28 days maximum after randomization (Day 28)).
Measured: At discharge or at 28 days maximum after randomization (Day 28))
Number and proportion of patients with a "Sepsis-related Organ Failure Assessment" (SOFA) score > 5, after randomization, at H24, Day 2, Day 3, Day 4.
Measured: 4 days
Ventilator-free days, vasopressor days, renal replacement therapy days
Ventilator-free days (Calculated by the subtracting the number of days spent on mechanical ventilation from 28), vasopressor days (calculated as the total number of days spent on inotropic drugs, for example noradrenaline), renal replacement therapy days (calculated as the total number of days spent on hemofiltration or hemodialysis).
Measured: 28 days
Total volume (mL) of fluids received at 24-hours including blood products and fluid resuscitation (crystalloids and colloids).
Measured: H24
Number and proportion of patients who died at H6, H24 and Day 28
- For any reason (crude mortality)
- By ISS score value (9-15=moderate trauma, 16-24 = severe trauma, ≥ 25 = very severe trauma) and stratified on the occurrence of brain-injury (defined by head AIS > 3), according to shock define by a lactate more than 3.9 mmol.l-1
- By attributable cause of death, including trauma brain injuries, bleeding, anoxia, sepsis, other The time median between randomization and the occurrence of death will be measured and compared between trial arms.
Measured: 28 days
Length of stay in the intensive care unit up to Day 28.
Measured: 28 days
Timing and the number of hemorrhage control procedures (surgery, interventional radiology) in the first 6-hours following admission.
Measured: 6 hours
Number and proportion of patients with grade 3 and 4 adverse events related to the management strategy between randomization and Day 28
- Ventilator-associated pneumonia
- Acute Respiratory Distress Syndrome (ARDS)
- Acute renal failure as defined by KDIGO (Kidney Disease / Improving Global Outcome 2012)
- Septic shock defined
- Any thromboembolic event; pulmonary embolism, deep vein thrombosis, gastrointestinal ischemia, non-traumatic limb ischemia, myocardial infarction, ischemic stroke.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma CoagulopathyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820879
- Sponsor's protocol ID
- 69HCL22_0937
- Acronym
- VISCOTAC
- Status last verified
- Jul 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viscoelastic Tests (VET) Versus Conventional Coagulation Tests (CCT) for Management of Trauma-Induced Coagulopathy: Opened, Randomized, Two-Parallel, Controlled Trial.VISCOTAC
- ClinicalTrials.gov ID
- NCT06820879
- Acronym / sponsor ID
- VISCOTAC / 69HCL22_0937
- Conditions
- Trauma Coagulopathy
- Keywords
- Coagulopathy, coagulation tests, viscoelastic tests, massives transfusions, labile blood products
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 11 Feb 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.
Traumatic coagulopathy is a complex, multifactorial event that occurs in 20-30% of patients on admission. It increases mortality, and its treatment is one of the main priorities in the early management of severely injured patients. Diagnosis of coagulopathy has traditionally been based on conventional coagulation tests (CCTs), which provide an assessment of patients' coagulation in over 60 minutes. Over the past fifteen years, viscoelastic tests (VETs) have been proposed, providing a more rapid result (≤ 10 min) and can guide the administration of labile blood products (LBP). Various studies, mainly retrospective, have shown that the use of VETs is associated with a significant reduction in the use of LBP and the incidence of massive transfusions (MT).
For example, it has been showed that the use of VETs was accompanied by a reduction in the administration of LBP and more particularly of RBC (Red blood cell concentrate) (4.8 units vs. 1.9 units). The investigators obtained the same result on a larger number of patients, with a further reduction in the administration of other LBP and in the incidence of MT (33% vs. 8%, p<0.01).
However, the main limitation of these 2 studies is that the results may not have been due solely to the use of ROTEM, but rather to a care package combining the use of ROTEM with the administration of tranexamic acid and the implementation of Damage Control Surgery techniques.
To avoid this methodological criticism, we recently compared 2 contemporary French cohorts (2012-2019), in which patients had similar management of traumatic injuries, with the exception of the type of coagulation tests: CCT vs. VET. The use of VET s was associated with an increase in the number of patients alive at 24h without MT (76% vs. 55%, p<0.001), but also with a sharp reduction in the administration of all LBPs.
This composite criterion associating the occurrence of a MT with survival at 24 hours after hospital admission was the primary endpoint of the randomized iTACTIC study. iTACTICS was published in 2021, and aimed to compare in severely injured patients 2 strategies for the diagnosis and treatment of coagulopathies, based on CCT in one arm and VET in the other. In this work, the use of VET was not associated with an improvement in the proportion of patients alive at 24 hours without MT (64% vs. 67%, OR 1.15, CI95%: 0.8-1.7), nor with any of the other criteria studied. The main limitation of this study is that less than a third of the patients included had a coagulopathy on admission. The probability of receiving LBP was therefore low. In the subgroup of the most severe patients, an improvement in the primary endpoint was observed for patients randomized to the VET group. The small sample size and subgroup analysis, however, limited the significance of this result.
All these elements suggest that it is necessary :
- to use a composite endpoint rather than a single endpoint (mortality) for the evaluation of VET-based strategies, combining early mortality with the occurrence of a transfusion event.
- conduct a randomized trial comparing the use of VETs with that of CCTs in trauma patients with a high probability of coagulopathy on admission to hospital.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm: conventional coagulation tests. | No intervention | –In this arm, patients will have a detection and a correction of the TIC based on conventional coagulation assays. The threshold used to initiate a correction, in case of ongoing bleeding, will be set at fibrinogen concentration ≤ 1.5 gr/L, PTratio >1.5 or platelets < 50 G.L-1 (< 100 G.L-1 in case of severe brain injury). |
| Viscoelastic arm: Viscoelastic Tests | Experimental | Device: Viscoelastic Tests (ROTEM)The detection and correction of TIC will be based on viscoelastic assay using values of clotting time (CT EXTEM), clot amplitude at 5 minutes (A5 FIBTEM and A5 EXTEM) and maximum lysis (ML). The algorithm for the study has been recently published and is based on thresholds for EXTEM (CT, A5 and ML), FIBTEM (A5). The algorithmic correction by fibrinogen concentrates and FFP is initiated using different cutoffs and parameters than in control arm, but the quantity of fibrinogen concentrates and FFP transfused will be similar in both arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Emergency procedure with secondary informed consent signed by the patient
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viscoelastic Tests (ROTEM)Viscoelastic Tests (2-6 tests for the study over the first 24 hours) | Device | Viscoelastic arm: Viscoelastic Tests |
Primary outcome
The survival without massive transfusion 24 hours after admission in the VET arm as compared to the CCT arm.
Time frame: 24hours after admission
24 hours after admission in the VET arm as compared to the CCT arm. The survival 24 hours after admission will be combine with the non-occurrence of massive transfusion (i.e., at least 10 units of RBC received at 24h). This comparison will be first carried out in a crude manner, and then considering the stratification factor, i.e., a Glasgow Coma Scale < 9 (severe traumatic brain injury) and administration of plasma (FFP or lyophilized plasma).
11 secondary outcomes
Number and proportion of patient receiving labile blood products, at 4, 6 and 24 hours after hospital admission.
Time frame: 4, 6 and 24 hours after hospital admission
Number and proportion of patients receiving fibrinogen concentrates as well as the quantity administered (in grams), at 6 and 24 hours after hospital admission
Time frame: 6 and 24 hours after hospital admission
Number and proportion of patients who received massive transfusion, time critical transfusion and Rescue therapy
Time frame: 24 hours
Number of RBCs received from admission to ICU discharge (or at 28 days maximum after randomization (Day 28)).
Time frame: At discharge or at 28 days maximum after randomization (Day 28))
Number and proportion of patients with a "Sepsis-related Organ Failure Assessment" (SOFA) score > 5, after randomization, at H24, Day 2, Day 3, Day 4.
Time frame: 4 days
Ventilator-free days, vasopressor days, renal replacement therapy days
Time frame: 28 days
Total volume (mL) of fluids received at 24-hours including blood products and fluid resuscitation (crystalloids and colloids).
Time frame: H24
Number and proportion of patients who died at H6, H24 and Day 28
Time frame: 28 days
Length of stay in the intensive care unit up to Day 28.
Time frame: 28 days
Timing and the number of hemorrhage control procedures (surgery, interventional radiology) in the first 6-hours following admission.
Time frame: 6 hours
Number and proportion of patients with grade 3 and 4 adverse events related to the management strategy between randomization and Day 28
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
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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.
Laurent VILLENEUVE contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viscoelastic Tests (ROTEM) in people with Trauma Coagulopathy, run by Hospices Civils de Lyon at 7 sites in France.
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 12 inclusion and 16 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: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Stephane DAVID (+33 4 78 86 41 40, jean-stephane.david@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survival without massive transfusion 24 hours after admission in the VET arm as compared to the CCT arm. (time frame: 24hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2025.