TraumaNCT03444077
Impact of a Prehospital Identification of Trauma Patients in Need for Damage Control Resuscitation.
A study testing Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool., Regular care and STTTOPPP the bleeding in people with Trauma and Coagulopathy, run by University of Liege at 4 sites in Belgium.
Trial summary
Early identification of trauma patients in need for Damage Control Resuscitation (DCR) has potential to be beneficial for general emergency units that are not expected to be ready for this rare situation 24 hours per day, 7 days per week. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Coagulopathy, Hemorrhage
- What is being tested?
- Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool., Regular care and STTTOPPP the bleeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesBelgium
- Study dates
- Jul 2018to Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- Prehospital intervention of paramedical or medical team involved in the present trial
- Admission in a hospital involved in this trial
Who cannot join
- Spontaneous admission without prehospital intervention
- Penetrating trauma
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Centre Hospitalier Universitaire St Pierre
Brussels
Bernard Kreps, MD, bernard_kreps@stpierre-bru.be
Cliniques Universitaires Saint Luc
Brussels
Maximilien Thoma, MD, maximilien.thoma@uclouvain.be
Réseau hospitalier de Jolimont
La Louvière
François Xavier Lens, MD, francois-xavier.lens@jolimont.be
Centre Hospitalier Universitaire de Liège
Liège
Frederic Swerts, MD, fswerts@chu.ulg.ac.be
About this study
Official title: Impact of a Prehospital Discrimination Between Trauma Patients With or Without Early Acute Coagulopathy of Trauma and the Need for Damage Control Resuscitation : a Multicenter Randomized Phase II Trial.
Early identification of trauma patients in need for Damage Control Resuscitation (DCR) has potential to be beneficial for general emergency units that are not expected to be ready for this rare situation 24 hours per day, 7 days per week. It could also be useful for high performing trauma centers to identify such patients earlier and be able to provide earlier adequate treatment.
By contrast, initiation of DCR in patients who do not require this aggressive therapy may negatively affect their survival. An early identification of patients who do not require DCR would probably be beneficial (impact on cost-effectiveness and on patients' survival).
Read more
The evidence of the Trauma Induced Coagulopathy Clinical Score (TICCS) accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated. There has never been any evaluation of the impact of a prehospital discrimination of trauma patients with or without the need for DCR.
The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for DCR. Secondary objectives include evaluation of the feasibility of such discrimination and its impact on cost-effectiveness. We hypothesize that the information will lead to improved quality of care with reduced mortality and morbidity.
Read the detailed description
The trial will be designed as randomized phase II clinical trial with comparison of the experimental protocol (prehospital discrimination using the TICCS) against the standard of care. Patients will be allocated in a 1:1 ratio in two groups: the intervention group will benefit from a prehospital evaluation using the TICCS and from a specific treatment protocol regarding the TICCS value. The control group will benefit from the standard local care.
The trial will involve several participating prehospital and hospital teams across Belgium.
Control and intervention group will only differ in the management of potential bleeding and coagulopathy. All patients will benefit from the recommended level of care regarding their situation, including airway management, Traumatic Brain Injury (TBI) management, control of external bleeding, cervical spine and extremities immobilization if needed …
Control group The patients allocated in the control group will be managed as recommended in the local guidelines and protocols. As the trial involves participating centers with different prehospital and hospital realities and local practices, the control group will reflect a wide panel of levels of care and will not be limited to a unique approach.
Intervention group The TICCS will be calculated on the site of injury for the patients taken in charge in the intervention group. Those patients will be classified in two categories regarding their TICCS value. Patients with TICCS ≥ 10 will be classified as in need for DCR; while patients with TICCS < 10 will be classified as not in need for DCR.
TICCS < 10 This subgroup will be considered without a need for DCR and without coagulopathy. There will not be any activation of the DCR components (no phone contact to the blood bank, to the surgical team, no prehospital transfusion). There will be any prehospital treatment/prevention of the hyperfibrinolysis using Tranexamic acid (TXA). Crystalloids infusion will be allowed. All patients will benefit from the recommended level of care regarding their situation (airway, TBI …), including trauma team activation if locally recommended.
TICCS ≥ 10
This subgroup will be considered with a need for DCR and with coagulopathy. They will be treated using the STTTOPPP the bleeding protocol. The STTTOPPP the bleeding protocol is the acronym for:
- Surgical team pre-activation
- Trauma team pre-activation
- Transfusion team pre-activation
- Tranexamic acid (administration of 1 gram of TXA if documented hyperfibrinolysis)
- O negative Red Blood Cells (RBC) transfusion as soon as possible
- Plasma and Platelets transfusion as soon as possible
- Permissive hypotension (restrictive use of crystalloids: no more than 500 milliliters before definitive control of the bleeding is achieved)
- Prophylaxis (initiate antithrombotic prophylaxis as soon as the bleeding is under control and coagulation tests are normal, first evaluation before the 24th hour after trauma)
Data will be collected locally in each participating center and will be anonymously recorded on the trial website by the local Principal Investigator or his research assistant. The website has been designed to avoid incomplete data, will give feedbacks (about the number of patients included) to this respective centers every six months. The participating centers will only have access to their own center database. The trial coordination team will have access to the whole database and will not be able to record or change any data. After one year of inclusion and in the end of the 24 months period of inclusion, data will be extracted for interim and final analysis.
- Conditions
- Trauma, Coagulopathy, Hemorrhage, Emergencies
- Being tested
- Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool., Regular care, STTTOPPP the bleeding
- Medical subject headings
- Wounds and Injuries, Hemostatic Disorders, Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool.Diagnostic test
The TICCS will be calculated on the site of injury for the patients taken in charge in the intervention group. Those patients will be classified in two categories regarding their TICCS value. Patients with TICCS ≥ 10 will be classified as in need for DCR; while patients with TICCS < 10 will be classified as not in need for DCR.
Regular careDiagnostic test
Patients from the control group will be evaluated by clinicians using the local usual clinical Tools.
STTTOPPP the bleedingOther
- Surgical team pre-activation
- Trauma team pre-activation
- Transfusion team pre-activation
- Tranexamic acid (administration of 1 gram of TXA if documented hyperfibrinolysis)
- O negative RBC transfusion as soon as possible
- Plasma and Platelets transfusion as soon as possible
- Permissive hypotension (restrictive use of crystalloids: no more than 500 milliliters before definitive control of the bleeding is achieved)
- Prophylaxis (initiate antithrombotic prophylaxis as soon as the bleeding is under control and coagulation tests are normal, first evaluation before the 24th hour after trauma)
Regular CareOther
Regular local pre-hospital care.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The patients allocated in the control group will be managed as recommended in the local guidelines and protocols. As the trial involves participating centers with different prehospital and hospital realities and local practices, the control group will reflect a wide panel of levels of care and will not be limited to a unique approach. Receives: Diagnostic Test: Regular care; Other: Regular Care |
| Intervention group | Experimental | Patients will be classified in two categories regarding their TICCS value. Patients with TICCS ≥ 10 will be classified as in need for DCR; while patients with TICCS < 10 will be classified as not in need for DCR.
TICCS < 10 This subgroup will be considered without a need for DCR and without coagulopathy. There will not be any activation of the DCR components (no phone contact to the blood bank, to the surgical team, no prehospital transfusion). There will be any prehospital treatment/prevention of the hyperfibrinolysis using Tranexamic acid (TXA). Crystalloids infusion will be allowed.
TICCS ≥ 10 This subgroup will be considered with a need for DCR and with coagulopathy. They will be treated using the STTTOPPP the bleeding protocol. Receives: Diagnostic Test: Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool.; Other: STTTOPPP the bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seven days mortality
Overall mortality
Measured: seven days
Secondary outcomes (3)
Thirty days mortality
Overall mortality
Measured: Thirty days
Hospital length-of-stay
Overall hospital length-of-stay
Measured: Thirty days
Blood products transfusion
Total number of blood products transfused during the hospitalization (units)
Measured: Thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study startJul 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin L Tonglet, University of Liege
- Investigators
- Alexandre Ghuysen, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444077
- Sponsor's protocol ID
- STTTOPPP the bleeding trial
- Status last verified
- May 2018
- First submitted
- 18 Feb 2018
- Last updated
- 2 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Prehospital Discrimination Between Trauma Patients With or Without Early Acute Coagulopathy of Trauma and the Need for Damage Control Resuscitation : a Multicenter Randomized Phase II Trial.
- ClinicalTrials.gov ID
- NCT03444077
- Acronym / sponsor ID
- STTTOPPP the bleeding trial
- Conditions
- Trauma, Coagulopathy, Hemorrhage, Emergencies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 23 Feb 2018 (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.
Early identification of trauma patients in need for Damage Control Resuscitation (DCR) has potential to be beneficial for general emergency units that are not expected to be ready for this rare situation 24 hours per day, 7 days per week. It could also be useful for high performing trauma centers to identify such patients earlier and be able to provide earlier adequate treatment.
By contrast, initiation of DCR in patients who do not require this aggressive therapy may negatively affect their survival. An early identification of patients who do not require DCR would probably be beneficial (impact on cost-effectiveness and on patients' survival).
The evidence of the Trauma Induced Coagulopathy Clinical Score (TICCS) accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated. There has never been any evaluation of the impact of a prehospital discrimination of trauma patients with or without the need for DCR.
The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for DCR. Secondary objectives include evaluation of the feasibility of such discrimination and its impact on cost-effectiveness. We hypothesize that the information will lead to improved quality of care with reduced mortality and morbidity.
Detailed description
The trial will be designed as randomized phase II clinical trial with comparison of the experimental protocol (prehospital discrimination using the TICCS) against the standard of care. Patients will be allocated in a 1:1 ratio in two groups: the intervention group will benefit from a prehospital evaluation using the TICCS and from a specific treatment protocol regarding the TICCS value. The control group will benefit from the standard local care.
The trial will involve several participating prehospital and hospital teams across Belgium.
Control and intervention group will only differ in the management of potential bleeding and coagulopathy. All patients will benefit from the recommended level of care regarding their situation, including airway management, Traumatic Brain Injury (TBI) management, control of external bleeding, cervical spine and extremities immobilization if needed …
Control group The patients allocated in the control group will be managed as recommended in the local guidelines and protocols. As the trial involves participating centers with different prehospital and hospital realities and local practices, the control group will reflect a wide panel of levels of care and will not be limited to a unique approach.
Intervention group The TICCS will be calculated on the site of injury for the patients taken in charge in the intervention group. Those patients will be classified in two categories regarding their TICCS value. Patients with TICCS ≥ 10 will be classified as in need for DCR; while patients with TICCS < 10 will be classified as not in need for DCR.
TICCS < 10 This subgroup will be considered without a need for DCR and without coagulopathy. There will not be any activation of the DCR components (no phone contact to the blood bank, to the surgical team, no prehospital transfusion). There will be any prehospital treatment/prevention of the hyperfibrinolysis using Tranexamic acid (TXA). Crystalloids infusion will be allowed. All patients will benefit from the recommended level of care regarding their situation (airway, TBI …), including trauma team activation if locally recommended.
TICCS ≥ 10
This subgroup will be considered with a need for DCR and with coagulopathy. They will be treated using the STTTOPPP the bleeding protocol. The STTTOPPP the bleeding protocol is the acronym for:
- Surgical team pre-activation
- Trauma team pre-activation
- Transfusion team pre-activation
- Tranexamic acid (administration of 1 gram of TXA if documented hyperfibrinolysis)
- O negative Red Blood Cells (RBC) transfusion as soon as possible
- Plasma and Platelets transfusion as soon as possible
- Permissive hypotension (restrictive use of crystalloids: no more than 500 milliliters before definitive control of the bleeding is achieved)
- Prophylaxis (initiate antithrombotic prophylaxis as soon as the bleeding is under control and coagulation tests are normal, first evaluation before the 24th hour after trauma)
Data will be collected locally in each participating center and will be anonymously recorded on the trial website by the local Principal Investigator or his research assistant. The website has been designed to avoid incomplete data, will give feedbacks (about the number of patients included) to this respective centers every six months. The participating centers will only have access to their own center database. The trial coordination team will have access to the whole database and will not be able to record or change any data. After one year of inclusion and in the end of the 24 months period of inclusion, data will be extracted for interim and final analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Diagnostic Test: Regular care, Other: Regular CareThe patients allocated in the control group will be managed as recommended in the local guidelines and protocols. As the trial involves participating centers with different prehospital and hospital realities and local practices, the control group will reflect a wide panel of levels of care and will not be limited to a unique approach. |
| Intervention group | Experimental | Diagnostic Test: Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool., Other: STTTOPPP the bleedingPatients will be classified in two categories regarding their TICCS value. Patients with TICCS ≥ 10 will be classified as in need for DCR; while patients with TICCS < 10 will be classified as not in need for DCR. TICCS < 10 This subgroup will be considered without a need for DCR and without coagulopathy. There will not be any activation of the DCR components (no phone contact to the blood bank, to the surgical team, no prehospital transfusion). There will be any prehospital treatment/prevention of the hyperfibrinolysis using Tranexamic acid (TXA). Crystalloids infusion will be allowed. TICCS ≥ 10 This subgroup will be considered with a need for DCR and with coagulopathy. They will be treated using the STTTOPPP the bleeding protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prehospital intervention of paramedical or medical team involved in the present trial
- Admission in a hospital involved in this trial
Key exclusion criteria (2 listed)
- Spontaneous admission without prehospital intervention
- Penetrating trauma
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 |
|---|---|---|
| Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool.The TICCS will be calculated on the site of injury for the patients taken in charge in the intervention group. Those patients will be classified in two categories regarding their TICCS value. Patients with TICCS ≥ 10 will be classified as in need for DCR; while patients with TICCS < 10 will be classified as not in need for DCR. | Diagnostic test | Intervention group |
| Regular carePatients from the control group will be evaluated by clinicians using the local usual clinical Tools. | Diagnostic test | Control group |
| STTTOPPP the bleeding* Surgical team pre-activation * Trauma team pre-activation * Transfusion team pre-activation * Tranexamic acid (administration of 1 gram of TXA if documented hyperfibrinolysis) * O negative RBC transfusion as soon as possible * Plasma and Platelets transfusion as soon as possible * Permissive hypotension (restrictive use of crystalloids: no more than 500 milliliters before definitive control of the bleeding is achieved) * Prophylaxis (initiate antithrombotic prophylaxis as soon as the bleeding is under control and coagulation tests are normal, first evaluation before the 24th hour after trauma) | Other | Intervention group |
| Regular CareRegular local pre-hospital care. | Other | Control group |
Primary outcome
Seven days mortality
Time frame: seven days
Overall mortality
3 secondary outcomes
Thirty days mortality
Time frame: Thirty days
Hospital length-of-stay
Time frame: Thirty days
Blood products transfusion
Time frame: Thirty days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: No
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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.
Alexandre Ghuysen, MD, PhD principal investigator
Centre Hospitalier Universitaire de Liege
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool., Regular care and STTTOPPP the bleeding in people with Trauma and Coagulopathy, run by University of Liege at 4 sites in Belgium.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin L Tonglet, MD, PhD (0032 4 366 77 21, tongletm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seven days mortality (time frame: seven days). 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 2 May 2018.