TraumaTRaViNCT05954936
Trauma Registry in Villavicencio, Colombia
An observational study of Trauma and Trauma Blunt, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Trauma, Trauma Blunt, Penetrating Wounds
- What is being tested?
- Risk factor
- How many people
- 250 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients admitted to the emergency ward by trauma.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Trauma, Trauma Blunt, Penetrating Wounds, Severe Trauma, Polytrauma, Registries
- Being tested
- Risk factor
- Keywords
- Wounds and Injuries, Trauma Severity Indices, Trauma Centers, Multiple Trauma, Registries, Data Collection, Routinely Collected Health Data, Colombia
- Medical subject headings
- Wounds and Injuries, Wounds, Nonpenetrating, Wounds, Penetrating, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factorOther
No therapeutic or diagnostic intervention will be provided; it is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Risk factor | |
| Penetrating injury | Penetrating wounds by guns, knives, and other penetrating injuries. Wounds that were caused by objects penetrating the skin. Receives: Other: Risk factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients dead
Mortality on discharge or the first 28 days of hospitalization
Measured: 28 days or discharge
Secondary outcomes (5)
Number of days in hospitalization
Hospital length of stay
Measured: 28 days or discharge
Number of patients needing ICU
Need of ICU
Measured: 28 days or discharge
Number of days in ICU
ICU length of stay
Measured: 28 days or discharge
Number of patients needing mechanical ventilation
Need of mechanical ventilation
Measured: 28 days or discharge
Number of days in mechanical ventilation
Length of mechanical ventilation
Measured: 28 days or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Jan 2024
- Primary completion30 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative University of Colombia
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez, MD, Principal investigator, Cooperative University of Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954936
- Sponsor's protocol ID
- GRIVI_2023_02_TRAUMA
- Acronym
- TRaVi
- Status last verified
- Dec 2024
- First submitted
- 11 Jul 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Database will not be shared to provide confidentiality to the identity of patients.
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.
PubMed 27821894Uribe 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.
PubMed 36856198Ordóñez 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.
PubMed 27573311Carius 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.
PubMed 34731068Arbizu-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.
PubMed 37226131Mandavia D, Newton K. Geriatric trauma. Emerg Med Clin North Am. 1998 Feb;16(1):257-74. doi: 10.1016/s0733-8627(05)70358-8.
PubMed 9496324Cleves 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.
PubMed 26879744Benjamin 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.
PubMed 35786669Fitschen-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.
PubMed 34773984
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Registry in a General Hospital From Villavicencio, Colombia, First Semester 2023: An Observational Retrospective Trial
- ClinicalTrials.gov ID
- NCT05954936
- Acronym / sponsor ID
- TRaVi / GRIVI_2023_02_TRAUMA
- Conditions
- Trauma, Trauma Blunt, Penetrating Wounds, Severe Trauma, Polytrauma, Registries
- Keywords
- Wounds and Injuries, Trauma Severity Indices, Trauma Centers, Multiple Trauma, Registries, Data Collection, Routinely Collected Health Data, Colombia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Collaborators
- Cooperative University of Colombia
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blunt injury | – | Other: Risk factorPatients 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. |
| Penetrating injury | – | Other: Risk factorPenetrating wounds by guns, knives, and other penetrating injuries. Wounds that were caused by objects penetrating the skin. |
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients admitted to the emergency ward by trauma.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk factorNo therapeutic or diagnostic intervention will be provided; it is an observational study. | Other | Blunt injury, Penetrating injury |
Primary outcome
Number of patients dead
Time frame: 28 days or discharge
Mortality on discharge or the first 28 days of hospitalization
5 secondary outcomes
Number of days in hospitalization
Time frame: 28 days or discharge
Number of patients needing ICU
Time frame: 28 days or discharge
Number of days in ICU
Time frame: 28 days or discharge
Number of patients needing mechanical ventilation
Time frame: 28 days or discharge
Number of days in mechanical ventilation
Time frame: 28 days or discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Results publication: PubMed 27821894Ordonez 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.
- Results publicationUribe 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.
- Results publication: PubMed 36856198Christey 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.
- Results publicationOrdóñez 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.
- Results publication: PubMed 27573311Eyler 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.
- Results publication: PubMed 34731068Carius 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.
- Results publication: PubMed 37226131Arbizu-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.
- Results publication: PubMed 9496324Mandavia D, Newton K. Geriatric trauma. Emerg Med Clin North Am. 1998 Feb;16(1):257-74. doi: 10.1016/s0733-8627(05)70358-8.
- Results publication: PubMed 26879744Cleves 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.
- Results publication: PubMed 35786669Benjamin 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.
- Results publication: PubMed 34773984Fitschen-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.
- Individual participant dataSharing planned: No. Database will not be shared to provide confidentiality to the identity of patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norton Perez, MD principal investigator
Cooperative University of Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Trauma Blunt, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients dead (time frame: 28 days or discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05954936, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.