Trauma Registry in Villavicencio, Colombia

Trauma Clinical Trial

— TRaVi  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05954936
• Other study ID #: GRIVI_2023_02_TRAUMA
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Hospital Departamental de Villavicencio
• Contact: Norton Perez, MD
• Phone: 6660154?
• Email: norton.perez[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 120 Years

Eligibility

Inclusion Criteria:

• Patients admitted to the emergency ward by trauma.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Multiple Trauma
• Polytrauma
• Registries
• Severe Trauma
• Trauma
• Wounds and Injuries
• Wounds, Penetrating

Intervention

Other:
• Risk factor
No therapeutic or diagnostic intervention will be provided; it is an observational study.

Locations

Country	Name	City	State
Colombia	Clinica Primavera	Villavicencio	Meta

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Departamental de Villavicencio	Cooperative University of Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (11)

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/s12873-023-00 — View Citation

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 TQ — View Citation

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. 202 — View Citation

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: — View Citation

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. — View Citation

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- — View Citation

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 Trauma — View Citation

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. — View Citation

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

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 — View Citation

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 T

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients dead	Mortality on discharge or the first 28 days of hospitalization	28 days or discharge
Secondary	Number of days in hospitalization	Hospital length of stay	28 days or discharge
Secondary	Number of patients needing ICU	Need of ICU	28 days or discharge
Secondary	Number of days in ICU	ICU length of stay	28 days or discharge
Secondary	Number of patients needing mechanical ventilation	Need of mechanical ventilation	28 days or discharge
Secondary	Number of days in mechanical ventilation	Length of mechanical ventilation	28 days or discharge