Trauma Registry in Villavicencio, Colombia (TRaVi)

Trauma Registry in a General Hospital From Villavicencio, Colombia, First Semester 2023: An Observational Retrospective Trial

Introduction: Injuries are a leading cause of mortality worldwide. It is necessary to know the incidence of injuries, mechanisms of wounds, therapy provided, and outcomes. Trauma registries are useful to describe the population served in specialized centers. Nevertheless, it is necessary also to identify the peculiarities of the event in the province and institutions non-dedicated to trauma attention.

Objective: The study aims to describe the initial experience with a trauma register in a general hospital in the Colombian Orinoquia.

Methodology: The investigators designed an observational retrospective study to analyze the admission database and revision of history charts of patients older than 15 years admitted for trauma from January to June 2023 in a hospital from Villavicencio, Colombia. The information will be exported to Excel for debugging and analysis. A description of the frequency and proportion of categorical variables will be performed; the central distribution and dispersion of quantitative variables will be reported. U of Mann-Whitney and Chi-square tests will be used to compare the variables by outcome; a p<0.05 was selected as a significant value.

Conclusions: It will be a pioneer study in this region, and it is necessary to evaluate the incidence of patients admitted by trauma, the mechanisms and type of injury, the care provided, and the outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma; Severe Trauma; Polytrauma; Registries; Trauma Blunt; Penetrating Wounds
• Intervention / Treatment: Other: Risk factor

Detailed Description

Trauma is a leading cause of global mortality or incapacitation in survivors. The population involved is mainly young adult men affected by preventable injuries. Knowing the incidence of injuries, mechanisms of wounds, approaching strategies, and outcomes is essential to review individual interventions and collective policies to improve prevention.

Casualties in Colombia had a high incidence in previous decades; injuries and attributable deaths have recently decreased, but they are still the third cause of mortality. Contrary to high-income countries, interpersonal violence is the predominant mechanism involved.

Data registries are used worldwide in specialized centers that focus on providing healthcare in trauma. Nevertheless, it is necessary also to know the incidence in community and non-dedicated general hospitals.

Determining the characteristics of patients admitted to the emergency ward by injuries will provide essential information on the severity, mechanisms, type of population affected, immediate or consequential care delivered, and outcomes. Such an analysis will give knowledge to prioritize policies, resources, upgrade clinical practice guidelines, and improve results.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Norton Perez, MD; Phone Number: 6660154‬; Email: norton.perez@hotmail.com
• Study Contact Backup: Name: Emma I Rodriguez, MSc; Phone Number: 6660154‬; Email: emmaisa1@hotmail.com

Study Locations

• Colombia
  • Meta
    • Villavicencio, Meta, Colombia, 50001
      • Clinica Primavera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The trial participants are those admitted requesting emergency attention by trauma during the study period, according to the registers of admission in the institution.

Description

Inclusion Criteria:

• Patients admitted to the emergency ward by trauma.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blunt injury; Patients with non-penetrating injuries from falls, car accidents, or other mechanisms. Injuries that were caused by impact with a blunt object where there is no penetration of the skin.	Other: Risk factor; No therapeutic or diagnostic intervention will be provided; it is an observational study.; Other Names: Severity
Penetrating injury; Penetrating wounds by guns, knives, and other penetrating injuries. Wounds that were caused by objects penetrating the skin.	Other: Risk factor; No therapeutic or diagnostic intervention will be provided; it is an observational study.; Other Names: Severity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients dead	Mortality on discharge or the first 28 days of hospitalization	28 days or discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days in hospitalization	Hospital length of stay	28 days or discharge
Number of patients needing ICU	Need of ICU	28 days or discharge
Number of days in ICU	ICU length of stay	28 days or discharge
Number of patients needing mechanical ventilation	Need of mechanical ventilation	28 days or discharge
Number of days in mechanical ventilation	Length of mechanical ventilation	28 days or discharge

Collaborators and Investigators

• Sponsor: Hospital Departamental de Villavicencio
• Collaborators: Cooperative University of Colombia
• Investigators: Principal Investigator: Norton Perez, MD, Cooperative University of Colombia

Publications and helpful links

General Publications

• Ordonez CA, Morales M, Rojas-Mirquez JC, Bonilla-Escobar FJ, Badiel M, Minan Arana F, Gonzalez A, Pino LF, Uribe-Gomez A, Herrera MA, Gutierrez-Martinez MI, Puyana JC, Abutanos M, Ivatury RR. Trauma Registry of the Pan-American Trauma Society: One year of experience in two hospitals in southwest Colombia. Colomb Med (Cali). 2016 Sep 30;47(3):148-154.
• Uribe A, Ordóñez CA, Badiel M, Tejada JW, Harry Loaiza J, Fernando Pino L, et al. Tendencia del trauma en dos hospitales nivel IV en Cali, Colombia. Reporte preliminar en la Plataforma del Registro de la Sociedad Panamericana de Trauma (SPT/RT). Panam J Trauma Crit Care Emerg Surg. 2012;1(3):175-81.
• Christey G, Warren J, Palmer CS, Burrell M, Vallmuur K. Development of a standardized minimum dataset for including low-severity trauma patients in trauma registry collections in Australia and Aotearoa New Zealand. ANZ J Surg. 2023 Mar;93(3):572-576. doi: 10.1111/ans.18326. Epub 2023 Mar 1.
• Ordóñez CA, Botache WF, Pino LF, Badiel M, Tejada JW, Sanjuán J, et al. Experiencia en dos hospitales de tercer nivel de atención del suroccidente de Colombia en la aplicación del Registro Internacional de Trauma de la Sociedad Panamericana de Trauma. Rev Colomb Cir. 2013;28(1):39-47.
• Eyler L, Hubbard A, Juillard C. Assessment of economic status in trauma registries: A new algorithm for generating population-specific clustering-based models of economic status for time-constrained low-resource settings. Int J Med Inform. 2016 Oct;94:49-58. doi: 10.1016/j.ijmedinf.2016.05.004. Epub 2016 Jun 29.
• Carius BM, Bebarta GE, April MD, Fisher AD, Rizzo J, Ketter P, Wenke JC, Salinas J, Bebarta VS, Schauer SG. A Retrospective Analysis of Combat Injury Patterns and Prehospital Interventions Associated with the Development of Sepsis. Prehosp Emerg Care. 2023;27(1):18-23. doi: 10.1080/10903127.2021.2001612. Epub 2021 Dec 22.
• Arbizu-Fernandez E, Echarri-Sucunza A, Galbete A, Fortun-Moral M, Belzunegui-Otano T. Epidemiology of severe trauma in Navarra for 10 years: out-of-hospital/ in-hospital deaths and survivors. BMC Emerg Med. 2023 May 24;23(1):54. doi: 10.1186/s12873-023-00818-6.
• Mandavia D, Newton K. Geriatric trauma. Emerg Med Clin North Am. 1998 Feb;16(1):257-74. doi: 10.1016/s0733-8627(05)70358-8.
• Cleves D, Gomez C, Davalos DM, Garcia X, Astudillo RE. Pediatric trauma at a general hospital in Cali, Colombia. J Pediatr Surg. 2016 Aug;51(8):1341-5. doi: 10.1016/j.jpedsurg.2016.01.008. Epub 2016 Feb 3.
• Benjamin ER, Demetriades D, Owattanapanich N, Shackelford SA, Roedel E, Polk TM, Biswas S, Rasmussen T. Therapeutic Interventions and Outcomes in Civilian and Military Isolated Gunshot Wounds to the Head: A Department of Defense Trauma Registry and ACS TQIP-matched Study. Ann Surg. 2023 Jul 1;278(1):e131-e136. doi: 10.1097/SLA.0000000000005496. Epub 2022 Jul 4.
• Fitschen-Oestern S, Lippross S, Lefering R, Kluter T, Weuster M, Franke GM, Kirsten N, Muller M, Schroder O, Seekamp A; TraumaRegister DGU. Does the time of the day affect multiple trauma care in hospitals? A retrospective analysis of data from the TraumaRegister DGU(R). BMC Emerg Med. 2021 Nov 13;21(1):134. doi: 10.1186/s12873-021-00525-0.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Wounds and Injuries; Trauma Centers; Registries; Trauma Severity Indices; Data Collection; Colombia; Multiple Trauma; Routinely Collected Health Data
• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma; Wounds, Penetrating
• Other Study ID Numbers: GRIVI_2023_02_TRAUMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Database will not be shared to provide confidentiality to the identity of patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No