Impact of a Prehospital Identification of Trauma Patients in Need for Damage Control Resuscitation.

Trauma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03444077
• Other study ID #: STTTOPPP the bleeding trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: March 2020

Study information

• Verified date: May 2018
• Source: University Hospital of Liege
• Contact: Martin L Tonglet, MD, PhD
• Phone: 0032 4 366 77 21
• Email: tongletm[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prehospital intervention of paramedical or medical team involved in the present trial

• Admission in a hospital involved in this trial

Exclusion Criteria:

• Spontaneous admission without prehospital intervention

• Penetrating trauma

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Emergencies
• Hemorrhage
• Hemostatic Disorders
• Trauma
• Wounds and Injuries

Intervention

Diagnostic Test:
• 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.
• Regular care
Patients from the control group will be evaluated by clinicians using the local usual clinical Tools.

Other:
• 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)
• Regular Care
Regular local pre-hospital care.

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Universitaire St Pierre	Brussel
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Réseau hospitalier de Jolimont	La Louvière
Belgium	Centre Hospitalier Universitaire de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seven days mortality	Overall mortality	seven days
Secondary	Thirty days mortality	Overall mortality	Thirty days
Secondary	Hospital length-of-stay	Overall hospital length-of-stay	Thirty days
Secondary	Blood products transfusion	Total number of blood products transfused during the hospitalization (units)	Thirty days