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

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.

Conditions

• Trauma
• Coagulopathy
• Hemorrhage
• Emergencies

Interventions

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.

DIAGNOSTIC_TEST

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)

OTHER

Regular Care

Regular local pre-hospital care.

Sponsors & Collaborators

• University of Liege

  lead OTHER

Principal Investigators

• Alexandre Ghuysen, MD, PhD · Centre Hospitalier Universitaire de Liege

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-31

Primary Completion

2019-03-31

Completion

2020-03-31

Countries

• Belgium

Study Locations