Viewing Study NCT06007807



Ignite Creation Date: 2024-05-06 @ 7:25 PM
Last Modification Date: 2024-10-26 @ 3:06 PM
Study NCT ID: NCT06007807
Status: COMPLETED
Last Update Posted: 2023-08-23
First Post: 2023-08-04

Brief Title: Severe Trauma Registry in Tarragona
Sponsor: Hospital Universitari Joan XXIII de Tarragona
Organization: Hospital Universitari Joan XXIII de Tarragona

Study Overview

Official Title: Registry of Patients With Severe Trauma Admitted to the ICU in Tarragona
Status: COMPLETED
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IcuTrauma
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
Detailed Description: Study design observational retrospective one centre Hospital Universitari Joan XXIII in Tarragona Catalonia Spain
Study period Seven-years period Since 01 January 2015 - 31 December 2022 The registry will be open and active recruiting after this time point
Sample size calculation Not applicable The sample size will be equal to the total number of patients consecutively admitted to the Intensive Care Unit ICU due to severe trauma during the study period
Data extraction

Data will be extracted by twofold

1 Hand-driven extracted data from the medical reports by reviewing the clinical history system performed by the study investigators who are part of the staff of the ICU involved in the care of trauma patients This information was collected into a large-scale database and once introduced the data was checked and verified by two investigators and principal investigator

These manually extracted data included pre-hospital variables such as the time of the injury the mechanism of injury first vital signs pre-hospital procedures in-hospital information demographics primary survey of trauma in emergency department-ED use of Extended Focused Assesment with Sonography in Trauma complete laboratory results in ED description of detailed anatomic injuries Traumatic Brain Injury-TBI thoracic trauma abdominal trauma Pelvic trauma orthopedic injuries severity scores Acute Physiology And Chronic Health Evaluation-APACHE II Sequential Organ Failure Assessment-SOFA score Injury Severity Score-ISS Abbreviated Injury Score-AIS etc resources during ICU admission surgeries transfusions organ support etc complications organ failures and nosocomial infections such as ventilator-associated pneumonia catheter-related infection etc and clinical outcomes ICU mortality cause of death in-hospital mortality one-year survival mechanical ventilation days ICU and hospital length of stay disability at ICU discharge and destination at discharge
2 Automatic data automated data collected with the Electronic Health System Centricity Critical Care provide solid and valid extraction of information Automatic variables were checked and validated by the expert and specialized members of the ICU in data quality assessment and the management of data to ensure that recorded information was reliable The accuracy completeness and representativeness of automatic data was double checked when entered into the large-scale database for data quality by the principal investigator and a biotechnologist who were responsible for the quality assurance plan that addressed data validation monitoring and auditing identifying inconsistencies outliers or incorrect ranges for variables entered into the registry The automated variables collected not recorded manually included demographic data comorbidities and previous risk factors dates hospital and ICU admission hospital and ICU discharge laboratory tests during the first week of ICU admission resources consumption during ICU stay complications during ICU admission and outcomes

Statistical plan descriptive and analytical statistics using binary logistic regression for association survival analysis with Kaplan Meier analysis and Cox regression for clinical outcomes nonlinear association test such as CHAID decision analysis and restricted cubic splines and matching learning analysis for cluster or subgroups identification These analyzes will be carried out using SPSS v24 and R software Missing data values of automated variables will be handled using multiple imputation Hand-driven data had negligible missing values
Variable definitions all definitions met the ATLS-Advanced Trauma Life Support criteria

Previous anticoagulants or antiplatelet agents chronic use of aspirin clopidogrel other antiplatelet agents acenocumarol warfarin new anticoagulants
Pre-hospital airway protection includes supraglottic device orotracheal intubation or surgical airway protection
Penetrating trauma knifes firearm impalement or others
Flail chest more than 3 ribs with fracture in two points
Lung contusion pulmonary infiltrate or condensation on initial X-rays after trauma
Hemothorax type simple any pleural fluid detected after trauma massive 15 Liters acute or 200cch in 2-4 hours
Type of pneumothorax simple presence of aire in pleural space hypertensive with hypotension andor respiratory failure
Myocardial dysfunction ventricular dysfunction detected in echocardiography or worsening of previous cardiac dysfunction
Abdominal injuries grade hepatic spleen and renal trauma anatomical scale injury using the AAST-The American Association for the Surgery of Trauma
Pelvic fracture classification Young-Burgees pelvic ring injury classification
Neurogenic shock bradycardia with hypoperfusion
Urgent surgery first 24 hours after trauma
Hemorragia shock hypoperfusion with or without hypotension defined by tachicardia coldness peripheral vasoconstriction need for vasopressors altered mental status oliguria hyperlactatemia or base excess deficit - 6 due to the loss of blood after injury
Damage control surgery Non-definitive surgery consisting in packing for hemorrhage control open abdomen intestinal contamination control
Massive hemorrhage 10 CH in the first 24 hours life-threatening hemorrhage or four blood products in the first 2 hours after admission
Intracranial hypertension ICH episode of Intracranial pressures 20-22 mmHg maintained for more than five minutes
First level of ICH measures general measures sedation neuromuscular blockade ventricular drainage osmotherapy
Second level of ICH measures decompressive craniectomy or brabiturics administration
Osmotherapy administration of hypertonic saline or mannitol during admission
Intracranial rebleeding increase in hematoma volume from initial tomography CT scan
Organ donor organ donation
ARDS Acute respiratory distress syndrome according the Berlin criteria
Protective mechanical ventilation applying tidal volumes 6-8 mlKg ideal body weight
Free liquid CT neither solid nor hollow viscera injury
Non-operative management NOM for abdominal trauma solid organ injury detected in CT scan managed through conservative management no need for surgery at least 6-8 hours
MNO failure urgent laparotomy after deciding NOM
White laparotomy absence of lesions observed in the laparotomy
Abdominal compartment syndrome results from the progression of steady-state pressure within the abdominal cavity to a repeated pathological elevation of pressure above 20mmHg with associated organ dysfunction
Early MODS Multiorgan dysfunction syndrome dysfunction of two or more organs in the first 72 hours after trauma
Renal failure according to AKIN guidelines
Trauma-induced Coagulopathy TIC prolongation of the prothrombin and activated partial thromboplastin times over 15 times the control values or fibrinogen 150 mgdL or thrombocytopenia 100000ml in the first 72 hours after trauma
Septic shock identification of sepsis plus organ failure or tissue hypoperfusion
Thrombosis any type deep vein thrombosis arterial pulmonary embolism
Tracheostomy percutaneous or surgical
Nosocomial infection any infection diagnosed after 48 hours of ICU admission
VAP Ventilator-associated pneumonia clinical and microbiologically confirmed pneumonia in patients ventilated for at least 48 hours
VAT Ventilator-associated tracheobronchitis upper respiratory tract infection without pneumonia in patients ventilated for at least 48h
CRI Catheter-related infection bacteremia with positive catheter culture for the same microorganism and no other source of infection with a minimum of 15 colony formation units in the catheter culture
Intra-abdominal infection peritonitis abscess positive surgical fluid
Infection of open fractures positive culture of the wound
MDR multidrug resistant infection includes any bacteria resistant to at least three antibiotic families
Limitation of life support withholding or withdrawal
Causes of death hemorrhagic shock early MODS late MODS septic shock refractory ICH without response to applied measures others

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None