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Traumatic Brain InjuriesTraVi_IINCT06776107

Mortality in Brain Injury at the Intensive Care Unit (TraVi II)

An observational study of Traumatic Brain Injuries, run by Hospital Departamental de Villavicencio at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: traumatic brain injuries are a leading cause of disability and mortality in the young population, associated mainly with traffic road accidents and violent wounds. The study aimed to analyze factors related to the mortality in patients with brain injury admitted to the intensive care unit. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Traumatic Brain Injuries
What is being tested?
Risk factor present
How many people
80 participants
Where
1 siteColombia
Study dates
1 Jan 2019to 30 Nov 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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population was patients with traumatic brain injury who were admitted to the intensive care unit.

Who may be able to join

  • Traumatic brain injury.
  • Admitted to the intensive care unit.

Who cannot join

  • Remission from another hospital.
  • Decease for causes other than the brain injury.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Hospital Departamental de Villavicencio

    Villavicencio, Meta Department, 50001

Other trials in Colombia

About this study

Official title: Factors Associated With Mortality in Brain Injury at the Intensive Care Unit. A Cross-sectional Trial, 2019-2023 (TraVi II)

Introduction: traumatic brain injuries are a leading cause of disability and mortality in the young population, associated mainly with traffic road accidents and violent wounds. The study aimed to analyze factors related to the mortality in patients with brain injury admitted to the intensive care unit.

Methodology: Between 2019 and 2024, an analytical cross-sectional trial at Hospital Departamental de Villavicencio, Colombia was performed. Information was selected from the intensive care unit (ICU) database. Variables of interest and outcomes, such as mortality and ICU length of stay, were identified. The comparison was performed with the software Prism® for Mac iOS and Wizard® for the predictive model.

Results: The study will show the factors associated with mortality of brain injury patients admitted to the intensive care unit.

Read the detailed description

Objective: The study aimed to analyze factors related to the mortality in patients with brain injury admitted to the intensive care unit.

Methodology: Between 2019 and 2024, an analytical cross-sectional trial at Hospital Departamental de Villavicencio, Colombia, a reference center for the Colombian Orinoco region with 400 hospital beds and 53 polyvalent ICU beds was performed. Information was selected from 2,154 admission registers in the intensive care unit (ICU) database. Data of admissions considered for review were from patients with diagnostic codes of brain injury, brain edema, polytrauma, ventilatory failure, neurogenic shock, and traumatic subarachnoid hemorrhage. All the registries with codes S00-S09 from the 10th revision of the International Diseases Classification from the World Health Organization were reviewed. Variables of interest and outcomes, such as mortality and ICU length of stay, were identified. The comparison was performed with the software Prism® for Mac iOS and Wizard® for the predictive model.

Results: The study will show the factors associated with mortality of brain injury patients admitted to the intensive care unit.

Being tested
Risk factor present
Keywords
Brain Injuries, Traumatic Brain Injuries, Brain Concussion, Traffic Accidents, Critical Care, Colombia
Medical subject headings
Brain Injuries, Traumatic, Brain Injuries, Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk factor presentOther

    Demographic, and severity.

Study groups in NCT06776107
Study groupRoleWhat they receive
MortalitySurvival
Receives: Other: Risk factor present

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICU mortality

    Mortality at the ICU

    Measured: 30 days

Secondary outcomes (1)

  1. ICU length of stay

    Length of stay at the intensive care unit.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study start1 Jan 2019
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06776107
Sponsor's protocol ID
GRIVI_2024_01_TCE
Acronym
TraVi_II
Status last verified
Jan 2025
First submitted
9 Dec 2024
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It contains sensible information about patients.

Publications

  • Ortega Zufiria JM, Prieto NL, Cuba BC, Degenhardt MT, Nunez PP, Lopez Serrano MR, Lopez Raigada AB. [Mild head injury]. Surg Neurol Int. 2018 Jan 22;9(Suppl 1):S16-S28. doi: 10.4103/sni.sni_371_17. eCollection 2018. Spanish.

    PubMed 29430327

  • Gonzalez-Robledo J, Martin-Gonzalez F, Moreno-Garcia M, Sanchez-Barba M, Sanchez-Hernandez F. Prognostic factors associated with mortality in patients with severe trauma: from prehospital care to the Intensive Care Unit. Med Intensiva. 2015 Oct;39(7):412-21. doi: 10.1016/j.medin.2014.06.004. Epub 2014 Sep 2. English, Spanish.

    PubMed 25189470

  • Fonseca J, Liu X, Oliveira HP, Pereira T. Mortality prediction using medical time series on TBI patients. Comput Methods Programs Biomed. 2023 Dec;242:107806. doi: 10.1016/j.cmpb.2023.107806. Epub 2023 Sep 21.

    PubMed 37832428

  • Buh FC, Sumbele IUN, Maas AIR, Motah M, Pattisapu JV, Youm E, Meh BK, Kobeissy FH, Wang KW, Hutchinson PJA, Taiwe GS. Traumatic Brain Injury in Cameroon: A Prospective Observational Study in a Level I Trauma Centre. Medicina (Kaunas). 2023 Aug 28;59(9):1558. doi: 10.3390/medicina59091558.

    PubMed 37763678

  • Domensino AF, Tas J, Donners B, Kooyman J, van der Horst ICC, Haeren R, Aries MJH, van Heugten C. Long-Term Follow-Up of Critically Ill Patients With Traumatic Brain Injury: From Intensive Care Parameters to Patient and Caregiver-Reported Outcome. J Neurotrauma. 2024 Jan;41(1-2):123-134. doi: 10.1089/neu.2022.0474. Epub 2023 Oct 10.

    PubMed 37265152

  • Launey Y, Coquet A, Lasocki S, Dahyot-Fizelier C, Huet O, Le Pabic E, Roquilly A, Seguin P. Factors associated with an unfavourable outcome in elderly intensive care traumatic brain injury patients. a retrospective multicentre study. BMC Geriatr. 2022 Dec 30;22(1):1004. doi: 10.1186/s12877-022-03651-x.

    PubMed 36585608

  • Rowe M, Brown J, Marsh A, Thompson J. Predicting Mortality Following Traumatic Brain Injury or Subarachnoid Hemorrhage: An Analysis of the Validity of Standardized Mortality Ratios Obtained From the APACHE II and ICNARC H-2018 Models. J Neurosurg Anesthesiol. 2023 Jul 1;35(3):292-298. doi: 10.1097/ANA.0000000000000831. Epub 2022 Feb 4.

    PubMed 35125410

  • Luostarinen T, Vehvilainen J, Lindfors M, Reinikainen M, Bendel S, Laitio R, Hoppu S, Ala-Kokko T, Skrifvars M, Raj R. Trends in mortality after intensive care of patients with traumatic brain injury in Finland from 2003 to 2019: a Finnish Intensive Care Consortium study. Acta Neurochir (Wien). 2022 Jan;164(1):87-96. doi: 10.1007/s00701-021-05034-4. Epub 2021 Nov 2.

    PubMed 34725728

  • Rubiano AM, Griswold DP, Jibaja M, Rabinstein AA, Godoy DA. Management of severe traumatic brain injury in regions with limited resources. Brain Inj. 2021 Sep 19;35(11):1317-1325. doi: 10.1080/02699052.2021.1972149. Epub 2021 Sep 7.

    PubMed 34493135

  • Kokkinou M, Kyprianou TC, Kyriakides E, Constantinidou F. A population study on the epidemiology and outcome of brain injuries in intensive care. NeuroRehabilitation. 2020;47(2):143-152. doi: 10.3233/NRE-203111.

    PubMed 32741786

  • Venkatasubba Rao CP, Suarez JI, Martin RH, Bauza C, Georgiadis A, Calvillo E, Hemphill JC 3rd, Sung G, Oddo M, Taccone FS, LeRoux PD; PRINCE Study Investigators. Global Survey of Outcomes of Neurocritical Care Patients: Analysis of the PRINCE Study Part 2. Neurocrit Care. 2020 Feb;32(1):88-103. doi: 10.1007/s12028-019-00835-z.

    PubMed 31486027

  • Pappacena S, Bailey M, Cabrini L, Landoni G, Udy A, Pilcher DV, Young P, Bellomo R. Early dysglycemia and mortality in traumatic brain injury and subarachnoid hemorrhage. Minerva Anestesiol. 2019 Aug;85(8):830-839. doi: 10.23736/S0375-9393.19.13307-X. Epub 2019 Feb 7.

    PubMed 30735020

  • Volovici V, Ercole A, Citerio G, Stocchetti N, Haitsma IK, Huijben JA, Dirven CMF, van der Jagt M, Steyerberg EW, Nelson D, Cnossen MC, Maas AIR, Polinder S, Menon DK, Lingsma HF. Intensive care admission criteria for traumatic brain injury patients across Europe. J Crit Care. 2019 Feb;49:158-161. doi: 10.1016/j.jcrc.2018.11.002. Epub 2018 Nov 8.

    PubMed 30447560

  • Raj R, Bendel S, Reinikainen M, Hoppu S, Luoto T, Ala-Kokko T, Tetri S, Laitio R, Koivisto T, Rinne J, Kivisaari R, Siironen J, Skrifvars MB. Traumatic brain injury patient volume and mortality in neurosurgical intensive care units: a Finnish nationwide study. Scand J Trauma Resusc Emerg Med. 2016 Nov 8;24(1):133. doi: 10.1186/s13049-016-0320-6.

    PubMed 27821129

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injuries, 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 2 inclusion and 2 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 15 Jan 2025. 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?

ICU mortality (time frame: 30 days). 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 NCT06776107, which also lists 14 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 15 Jan 2025.

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