Global Neurotrauma Outcomes Study: Spine

NCT05883618 | Unknown DMC

• 1 other identifier: GNOSSpine
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Injury; Trauma

Keywords

Traumatic spine injury; Global burden

Outcome Measures

Primary Outcomes (1)

• Frankel Grade

  A = complete motor and sensory loss (poor outcome), E = no neurological symptoms or signs (good outcome)

  At discharge or 6 weeks post-admission, whichever comes first

Secondary Outcomes (5)

• Mortality

  At discharge or 6 weeks post-admission, whichever comes first

• Length of Stay

  At discharge or at 6 weeks post-admission (whichever comes first)

• Peri-operative Complications

  At discharge or at 6 weeks post-admission (whichever comes first)

• Independence with activities of daily living (ADLs)

  At discharge or at 6 weeks post-admission (whichever comes first)

• Mobility

  At discharge or at 6 weeks post-admission (whichever comes first)

Study Arms (1)

Radiologically confirmed traumatic spine injury

Other: Exposure

Interventions

Exposure OTHER

Human Development Index of Country

Radiologically confirmed traumatic spine injury

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

All adult patients with radiologically confirmed traumatic spine injury

You may qualify if:

• 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.

You may not qualify if:

• Elective (planned) or semi-elective (patient initially discharged after emergency with planned
• intervention at a future date) admissions

Sponsors & Collaborators

• University of Cambridge: lead
• NIHR Global Health Research Group on Neurotrauma: collaborator

Study Sites (1)

University of Cambridge

Cambridge, County, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Back Injuries

Study Officials

• Saniya Mediratta

  NIHR Global Health Research Group on Neurotrauma

  PRINCIPAL INVESTIGATOR

• Jibin Francis

  NIHR Global Health Research Group on Neurotrauma

  PRINCIPAL INVESTIGATOR

• Peter Hutchinson

  NIHR Global Health Research Group on Neurotrauma

  PRINCIPAL INVESTIGATOR

• Rikin Trivedi

  NIHR Global Health Research Group on Neurotrauma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saniya Mediratta

CONTACT

+441223336946; info@globalspinetrauma.com

Rikin Trivedi

CONTACT

+441223336946; info@globalspinetrauma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principle Investigator

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: June 1, 2023
• Study Start: July 12, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication of the main results

Locations

GB (1)