Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05883618
Status:
UNKNOWN
Last Update Posted:
2023-06-01
First Post:
2023-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Global Neurotrauma Outcomes Study: Spine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D019567', 'term': 'Back Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-12', 'size': 526781, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-21T14:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-21', 'studyFirstSubmitDate': '2023-03-05', 'studyFirstSubmitQcDate': '2023-05-21', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frankel Grade', 'timeFrame': 'At discharge or 6 weeks post-admission, whichever comes first', 'description': 'A = complete motor and sensory loss (poor outcome), E = no neurological symptoms or signs (good outcome)'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'At discharge or 6 weeks post-admission, whichever comes first', 'description': 'Assessment of survival'}, {'measure': 'Length of Stay', 'timeFrame': 'At discharge or at 6 weeks post-admission (whichever comes first)', 'description': 'Hospital and ICU'}, {'measure': 'Peri-operative Complications', 'timeFrame': 'At discharge or at 6 weeks post-admission (whichever comes first)', 'description': 'Return to operating theatre, surgical site infections, adverse events of special interest (pressure ulcer, pneumonia, DVT)'}, {'measure': 'Independence with activities of daily living (ADLs)', 'timeFrame': 'At discharge or at 6 weeks post-admission (whichever comes first)', 'description': 'Rating of specific ADLs as unaided, with aid or completely dependent'}, {'measure': 'Mobility', 'timeFrame': 'At discharge or at 6 weeks post-admission (whichever comes first)', 'description': 'Mechanism of mobility e.g. mobilising independently, mobilising with a frame, wheelchair, bed bound etc.)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic spine injury', 'Global burden'], 'conditions': ['Spine Injury', 'Trauma']}, 'descriptionModule': {'briefSummary': 'Primary aim:\n\nCharacterise 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.\n\nPrimary outcome measure:\n\nThe primary outcome measure will be Frankel Grade at 6 weeks post-admission (or discharge, whichever comes first).\n\nPrimary comparison:\n\nBetween country groups defined by human development index\n\nCentre eligibility:\n\nAny unit assessing patients with TSI worldwide will be eligible to participate\n\nPatient eligibility:\n\nAll adult patients presenting with radiologically confirmed traumatic spinal injury.\n\nTeam:\n\nEach 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.\n\nTime period:\n\nLocal 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.\n\nValidation:\n\nThere 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.', 'detailedDescription': '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.\n\nObjectives 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.\n\nMethods 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.\n\nResults 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.\n\nConclusions 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients with radiologically confirmed traumatic spine injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Centre inclusion Criteria\n\n* Any primary, secondary or tertiary institution worldwide managing patients with TSI is eligible to participate.\n* 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.\n\nPatient inclusion and exclusion criteria Inclusion Criteria\n\n* 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.\n\nExclusion Criteria\n\n* Elective (planned) or semi-elective (patient initially discharged after emergency with planned\n* intervention at a future date) admissions\n* 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)'}, 'identificationModule': {'nctId': 'NCT05883618', 'acronym': 'GNOS Spine', 'briefTitle': 'Global Neurotrauma Outcomes Study: Spine', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'Global Neurotrauma Outcomes Study: Spine', 'orgStudyIdInfo': {'id': 'GNOSSpine'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiologically confirmed traumatic spine injury', 'interventionNames': ['Other: Exposure']}], 'interventions': [{'name': 'Exposure', 'type': 'OTHER', 'description': 'Human Development Index of Country', 'armGroupLabels': ['Radiologically confirmed traumatic spine injury']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cambridge', 'state': 'County', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Saniya Mediratta', 'role': 'CONTACT'}], 'facility': 'University of Cambridge', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Saniya Mediratta', 'role': 'CONTACT', 'email': 'info@globalspinetrauma.com', 'phone': '+441223336946'}, {'name': 'Rikin Trivedi', 'role': 'CONTACT', 'email': 'info@globalspinetrauma.com', 'phone': '+441223336946'}], 'overallOfficials': [{'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', 'affiliation': 'NIHR Global Health Research Group on Neurotrauma'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Following publication of the main results', 'ipdSharing': 'YES', 'description': 'After publication of the main results, the pooled dataset will be available to all members of the GNOS Spine collaboration for secondary analysis, after judgement and approval of each proposed analysis by the central study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'NIHR Global Health Research Group on Neurotrauma', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principle Investigator', 'investigatorFullName': 'Saniya Mediratta', 'investigatorAffiliation': 'University of Cambridge'}}}}