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Global Neurotrauma Outcomes Study: Spine

NCT05883618 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-06-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Exposure

Human Development Index of Country

Sponsors & Collaborators

Principal Investigators

  • Saniya Mediratta · NIHR Global Health Research Group on Neurotrauma

  • Jibin Francis · NIHR Global Health Research Group on Neurotrauma

  • Peter Hutchinson · NIHR Global Health Research Group on Neurotrauma

  • Rikin Trivedi · NIHR Global Health Research Group on Neurotrauma

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2023-05-30
Completion
2023-05-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05883618 on ClinicalTrials.gov