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

NCT ID: NCT06776107

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injuries

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Mortality

Survival

Risk factor present

Intervention Type OTHER

Demographic, and severity.

Interventions

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Risk factor present

Demographic, and severity.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Remission from another hospital.
* Decease for causes other than the brain injury.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Departamental de Villavicencio

OTHER

Sponsor Role lead

Responsible Party

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Norton Perez-Gutierrez, MD

ICU chief of staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norton Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Departamental de Villavicencio

Locations

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Hospital Departamental de Villavicencio

Villavicencio, Meta Department, Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type RESULT
PMID: 29430327 (View on PubMed)

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.

Reference Type RESULT
PMID: 25189470 (View on PubMed)

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.

Reference Type RESULT
PMID: 37832428 (View on PubMed)

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.

Reference Type RESULT
PMID: 37763678 (View on PubMed)

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.

Reference Type RESULT
PMID: 37265152 (View on PubMed)

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.

Reference Type RESULT
PMID: 36585608 (View on PubMed)

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.

Reference Type RESULT
PMID: 35125410 (View on PubMed)

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.

Reference Type RESULT
PMID: 34725728 (View on PubMed)

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.

Reference Type RESULT
PMID: 34493135 (View on PubMed)

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.

Reference Type RESULT
PMID: 32741786 (View on PubMed)

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.

Reference Type RESULT
PMID: 31486027 (View on PubMed)

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.

Reference Type RESULT
PMID: 30735020 (View on PubMed)

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.

Reference Type RESULT
PMID: 30447560 (View on PubMed)

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.

Reference Type RESULT
PMID: 27821129 (View on PubMed)

Other Identifiers

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GRIVI_2024_01_TCE

Identifier Type: -

Identifier Source: org_study_id

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