Outcome in Traumatic Brain Injury Elderly Patients

NCT04651803 | Completed

• 1 other identifier: ATLANREA
• Study Type: observational
• Target: 1,633
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients suffering from traumatic brain injury (TBI), the study's purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged ≥ 65 hospitalized in ICU and to compare outcome at 3 months between younger patients (18-64 years) vs older patients (≥65 years). Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37% of all injury-related death in Europe. This was particularly true for patients ≥ 65 years old and in the most severe case(Glasgow coma score ≤ 8) with mortality rates between 31 to 51%. Over time, epidemiological patterns of TBI are changing. Indeed, in high-income countries, overall incidence is steadily decreasing, but increasing in elderly population with falls becoming the leading cause of TBI. In parallel, the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 (9%) million persons aged ≥65 years in the global population and that this proportion is projected to rise further to 16 % in 2050. Accordingly, we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades. In a study performed in three neuro-intensive care unit (ICUs) from 1997 to 2007, 6-month mortality in patients aged of 70-79 and ≥ 80 years was 59% and 79%, respectively. In severe elderly (≥ 65 years) TBI patients admitted in ICU, hospital and 6-month mortality was 64.6% and 72.9%, respectively. Beyond mortality, TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities, frequent use of oral anticoagulants and/or antiplatelet and/or previous brain disorders. In patients hospitalized in ICU, age (\> 59 years) was the strongest parameter associated with an unfavorable outcome including death, vegetative state and severe disability, at 6 month. Moreover, TBI elderly patients (≥ 65 years) had worse functional outcome at discharge than younger patients. Identifying elderly patients who may benefit from ICU remained challenging, since there is no consensual guideline of triage. Traumatic brain-injured patients are particularly concerned by this issue. Nevertheless, few data are available related to outcome in elderly TBI patients requiring ICU.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Outcome was assessed using the Glasgow Outcome Scale Extended (GOSE) score

  We dichotomized the GOSE score between the four lower values (corresponding to unfavorable outcome- GOSE 1 to 4) and the four upper values (corresponding to favorable outcome- GOSE 5 to 8).

  GOSE score at 3 months.

Study Arms (1)

Traumatic brain injury patients

Traumatic brain injury patients admitted in intensive care unit.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic brain injury

You may qualify if:

• Traumatic brain injury
• Aged at least 18 years,
• Hospitalized in intensive care unit

You may not qualify if:

• Patients who die within 24h of hospitalization
• Patients initially resuscitated awaiting for organ donation
• Refusal for study participation expressed by the patient or relatives.
• Missing data related to the main objective of the study (outcome at 3 months)

Sponsors & Collaborators

• Association pour la Recherche en Aanesthésie Réanimation Digestive: lead

Related Publications (10)

• Roozenbeek B, Maas AI, Menon DK. Changing patterns in the epidemiology of traumatic brain injury. Nat Rev Neurol. 2013 Apr;9(4):231-6. doi: 10.1038/nrneurol.2013.22. Epub 2013 Feb 26.

  PMID: 23443846 BACKGROUND

• Stocchetti N, Paterno R, Citerio G, Beretta L, Colombo A. Traumatic brain injury in an aging population. J Neurotrauma. 2012 Apr 10;29(6):1119-25. doi: 10.1089/neu.2011.1995. Epub 2012 Apr 2.

  PMID: 22220762 BACKGROUND

• Maiden MJ, Cameron PA, Rosenfeld JV, Cooper DJ, McLellan S, Gabbe BJ. Long-Term Outcomes after Severe Traumatic Brain Injury in Older Adults. A Registry-based Cohort Study. Am J Respir Crit Care Med. 2020 Jan 15;201(2):167-177. doi: 10.1164/rccm.201903-0673OC.

  PMID: 31657946 BACKGROUND

• Gardner RC, Dams-O'Connor K, Morrissey MR, Manley GT. Geriatric Traumatic Brain Injury: Epidemiology, Outcomes, Knowledge Gaps, and Future Directions. J Neurotrauma. 2018 Apr 1;35(7):889-906. doi: 10.1089/neu.2017.5371. Epub 2018 Feb 15.

  PMID: 29212411 BACKGROUND

• Lim XT, Ang E, Lee ZX, Hajibandeh S, Hajibandeh S. Prognostic significance of preinjury anticoagulation in patients with traumatic brain injury: A systematic review and meta-analysis. J Trauma Acute Care Surg. 2021 Jan 1;90(1):191-201. doi: 10.1097/TA.0000000000002976.

  PMID: 33048909 BACKGROUND

• Susman M, DiRusso SM, Sullivan T, Risucci D, Nealon P, Cuff S, Haider A, Benzil D. Traumatic brain injury in the elderly: increased mortality and worse functional outcome at discharge despite lower injury severity. J Trauma. 2002 Aug;53(2):219-23; discussion 223-4. doi: 10.1097/00005373-200208000-00004.

  PMID: 12169925 BACKGROUND

• De Bonis P, Pompucci A, Mangiola A, Paternoster G, Festa R, Nucci CG, Maviglia R, Antonelli M, Anile C. Decompressive craniectomy for elderly patients with traumatic brain injury: it's probably not worth the while. J Neurotrauma. 2011 Oct;28(10):2043-8. doi: 10.1089/neu.2011.1889. Epub 2011 Aug 29.

  PMID: 21639728 BACKGROUND

• Pettigrew LE, Wilson JT, Teasdale GM. Reliability of ratings on the Glasgow Outcome Scales from in-person and telephone structured interviews. J Head Trauma Rehabil. 2003 May-Jun;18(3):252-8. doi: 10.1097/00001199-200305000-00003.

  PMID: 12802167 BACKGROUND

• Majdan M, Plancikova D, Brazinova A, Rusnak M, Nieboer D, Feigin V, Maas A. Epidemiology of traumatic brain injuries in Europe: a cross-sectional analysis. Lancet Public Health. 2016 Dec;1(2):e76-e83. doi: 10.1016/S2468-2667(16)30017-2. Epub 2016 Nov 29.

  PMID: 29253420 RESULT

• 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.

  PMID: 36585608 DERIVED

Related Links

• World Population Ageing 2019

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Philippe Seguin, MD, PhD

  AtlanRéa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: April 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-12