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

NCT03444077 | Unknown

• 1 other identifier: STTTOPPP the bleeding trial
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Seven days mortality

  Overall mortality

  seven days

Secondary Outcomes (3)

• Thirty days mortality

  Thirty days

• Hospital length-of-stay

  Thirty days

• Blood products transfusion

  Thirty days

Study Arms (2)

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.

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.

Diagnostic Test: Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool.; Other: STTTOPPP the bleeding

Interventions

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.

Intervention group

Regular Care DIAGNOSTIC_TEST

Patients from the control group will be evaluated by clinicians using the local usual clinical Tools.

Control group

STTTOPPP the bleeding OTHER

* 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)

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prehospital intervention of paramedical or medical team involved in the present trial
• Admission in a hospital involved in this trial

You may not qualify if:

• Spontaneous admission without prehospital intervention
• Penetrating trauma

Sponsors & Collaborators

• University of Liege: lead

Study Sites (4)

Centre Hospitalier Universitaire St Pierre

Brussels, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Réseau hospitalier de Jolimont

La Louvière, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Location

MeSH Terms

Conditions

Wounds and Injuries; Hemostatic Disorders; Hemorrhage; Emergencies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Alexandre Ghuysen, MD, PhD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin L Tonglet, MD, PhD

CONTACT

0032 4 366 77 21; tongletm@yahoo.com

Frederic Swerts, MD

CONTACT

0032 4 366 77 21; fswerts@chu.ulg.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: February 23, 2018
• Study Start: July 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)