Clinical trial NCT05883618: Global Neurotrauma Outcomes Study: Spine
Official title: Global Neurotrauma Outcomes Study: Spine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Injury
Trauma
Keywords: Traumatic spine injury
Global burden
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: NIHR Global Health Research Group on Neurotrauma
First posted: 2023-06-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with radiologically confirmed traumatic spine injury

Brief summary: Primary aim:

Characterise case-mix, processes of care and variations in nonoperative and operative management strategies, including emergency, ward, surgical and ICU care, in patients presenting with traumatic spinal injury (TSI) between centres across low and high Human Development Index (HDI) countries.

Primary outcome measure:

The primary outcome measure will be Frankel Grade at 6 weeks post-admission (or discharge, whichever comes first).

Primary comparison:

Between country groups defined by human development index

Centre eligibility:

Any unit assessing patients with TSI worldwide will be eligible to participate

Patient eligibility:

All adult patients presenting with radiologically confirmed traumatic spinal injury.

Team:

Each participating unit will form a study team of up to four investigators including a study lead, local investigator 1/2 and an independent data validator.

Time period:

Local study teams may select any 30-day period from July 12th 2021 to start their study. Patients who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included.

Validation:

There will be a two-phase data validation process. Phase 1 will be prospective, validating case ascertainment, and phase 2 will be retrospective, validating operative data.

Detailed description: Background Traumatic spinal injury (TSI) accounts for a significant proportion of disability and death worldwide, with the majority of this burden affecting individuals in low- to middle- income countries. Crucially, to date, the current disease profile of TSI has not been characterised globally. In addition, the global approach to the care of patients following TSI is inconsistent with considerable geographical differences in process of care reported, and limited data available on the impact of these variations on outcomes following TSI. A better understanding of case-mix and processes of care is urgently needed to underpin efforts to identify ways of improving outcome relevant to different socioeconomic settings globally.

Objectives The primary objective of this study is to characterise the case-mix, processes of care and variations in nonoperative and operative management strategies, including emergency, ward, ICU care, in patients presenting with traumatic spinal injury (TSI) between centres across low and high Human Development Index (HDI) countries. The secondary aims are to summarise current local resources and management pathways for TSI through validation of provider profiling data, describe differences in indications for nonoperative and operative management, and short-term outcomes following TSI. This study aims to identify gaps in processes of care to identify targets for future interventions to improve TSI care across high and low-resource settings.

Methods A multi-centre, international, prospective, observational study. Any unit assessing patients with TSI worldwide will be eligible to participate. Each participating unit will form a study team responsible for gaining local approval, identifying patients for inclusion and conducting data collection. Data will be collected via a secure online platform in an anonymised form. Processes of care will be characterised by a detailed provider profiling exercise. A registry describing the case-mix and care of all adults presenting with radiologically confirmed TSI will be collected, in a given consecutive 30-day period during the study period starting in 2021.

Results The dataset, developed through an iterative feedback process involving clinicians from low and high Human Development Index (HDI) countries, includes patient demographics, details of injury mechanism, local injury management and, if applicable, timing and nature of surgery, post-operative care and immediate postoperative complications. Outcome measures include Frankel grade at 6 weeks post-admission (or at discharge or death, whichever event occurs first), early mortality, peri-operative complications, adverse events of special interest, functional status and mobility. Descriptive analyses of case-mix and the variations in processes of care will be conducted. Available resources, use of guidelines and variations in processes of care will be characterised using both provider profiling responses and patient-level data collected. Areas where known best practice is deficient or unavailable will be identified as potential targets for future implementation studies.

Conclusions GNOS Spine aims to provide a global snapshot of the case-mix, management, processes of care and short-term outcomes of patients presenting with TSI. In addition, the study aims to identify areas for further study, and establish a platform and clinical network to facilitate this future research in global neurotrauma and spinal surgery.

Eligibility criteria: Centre inclusion Criteria

* Any primary, secondary or tertiary institution worldwide managing patients with TSI is eligible to participate.
* In many institutions, management for TSI may be provided by spinal surgeons - however, centres in which management for TSI is provided by general surgeons, trauma surgeons, general medical doctors or even non-physician clinicians are also eligible to participate.

Patient inclusion and exclusion criteria Inclusion Criteria

* All adult patients presenting to the participating institution with a first presentation of TSI confirmed radiographically, during the selected 30-day inclusion period are eligible for inclusion in the core study.

Exclusion Criteria

* Elective (planned) or semi-elective (patient initially discharged after emergency with planned
* intervention at a future date) admissions
* Patients who have previously had an admission for TSI rendering them eligible for inclusion in this study (regardless of whether they were included on the previous admission or not)

Primary outcomes:
measure: Frankel Grade
timeFrame: At discharge or 6 weeks post-admission, whichever comes first
Secondary outcomes:
measure: Mortality
timeFrame: At discharge or 6 weeks post-admission, whichever comes first
measure: Length of Stay
timeFrame: At discharge or at 6 weeks post-admission (whichever comes first)
measure: Peri-operative Complications
timeFrame: At discharge or at 6 weeks post-admission (whichever comes first)
measure: Independence with activities of daily living (ADLs)
timeFrame: At discharge or at 6 weeks post-admission (whichever comes first)
measure: Mobility
timeFrame: At discharge or at 6 weeks post-admission (whichever comes first)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge
state: County
Study officials:
affiliation: NIHR Global Health Research Group on Neurotrauma
name: Saniya Mediratta
role: PRINCIPAL_INVESTIGATOR
affiliation: NIHR Global Health Research Group on Neurotrauma
name: Jibin Francis
role: PRINCIPAL_INVESTIGATOR
affiliation: NIHR Global Health Research Group on Neurotrauma
name: Peter Hutchinson
role: PRINCIPAL_INVESTIGATOR
affiliation: NIHR Global Health Research Group on Neurotrauma
name: Rikin Trivedi
role: PRINCIPAL_INVESTIGATOR
References: