Severe Trauma Registry in Tarragona

NCT06007807 | Completed

• 1 other identifier: ICUTRAUMA
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Severe trauma is one of the leading causes of morbidity, mortality, and disability worldwide. Currently, it is the primary cause of death among individuals under 45 years of age. This disease, considered a "silent pandemic," exhibits heterogeneous physiopathology and unequal geographic distribution in terms of the type of injuries. The prognosis of subjects who have suffered severe trauma is uncertain, especially in patients with traumatic brain injury. The epidemiology of severe trauma has undergone changes in recent years due to the global aging of society, resulting in different populations with older ages and more associated comorbidities. These factors are frequently linked to the use of chronic treatments such as antiplatelet agents or anticoagulants, which could worsen traumatic hemorrhage-the leading preventable cause of death following severe trauma. Despite efforts for primary prevention, such as road safety campaigns and occupational risk prevention, the annual incidence of severe trauma cases worldwide remains high. Enhancing the management of trauma patients would significantly influence the final clinical outcomes. Given the aforementioned, it is of vital importance to understand the local epidemiology of severe trauma for the development of clinical research. This constitutes an effective tool to investigate changes in clinical practices, improve prevention strategies, and determine the global burden of the disease. The hypothesis of the IcuTrauma Project is to create a territorial Registry of adults with severe trauma admitted to the ICU to understand the local epidemiology in Tarragona (Spain). This initiative would facilitate new lines of clinical research aimed at improving outcomes and the quality of care for trauma patients.

Conditions

Major Trauma; Traumatic Brain Injury

Keywords

Severe trauma; Traumatic Brain Injury; ICU; Mortality; Trauma-induced coagulopathy; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• ICU mortality

  proportion of deaths

  Time (in days) between ICU admission date and ICU discharge date

Secondary Outcomes (3)

• Length of stay (LOS)

  Time (in days) between hospital admission date and hospital discharge date

• Mechanical ventilation duration

  During the invasive mechanical ventilation treatment

• In-hospital mortality

  at 28 day

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting a severe trauma in the province of Tarragona and transferred to the Joan XXIII Hospital (Tarragona City), either as primary or secondary transfer. The ICUTRAUMA project was conducted in one center (Joan XXIII University Hospital), which is the reference center in the province. It is a Level II Trauma Center. It has 24-hours neurosurgery and ICU availability, being the reference centre in the province for patients with TBI. The Joan XXIII Hospital receives patients with severe trauma from other six centers. The entire province covers a total surface area of 6,302 km2 with almost 1M inhabitants. According to our general data, more than 400 patients are admitted to the hospital emergency department each year, of which more than 100 patients require admission to the ICU.

You may qualify if:

• Adults who were consecutevely admitted to the ICU for severe trauma during the study period.

You may not qualify if:

• Children aged \< 15 years old.
• Trauma admitted outside the ICU

Sponsors & Collaborators

• Hospital Universitari Joan XXIII de Tarragona.: lead

Study Sites (1)

Hospital Universitari Joan XXIII

Tarragona, Catalonia/Tarragona, 43005, Spain

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Wounds and Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerard Moreno, PhD

  Hospital Universitari Joan XXIII

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Staff of Intensive Care Unit

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 23, 2023
• Study Start: January 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

ES (1)