Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964764
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-06-22
Brief Title:
Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Sponsor:
Halmstad County Hospital
Organization:
Halmstad County Hospital
Study Overview
Official Title:
A Pragmatic Prospective Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHIPP
Brief Summary:
Head injuries are common among children and adolescents with many of them assessed in emergency departments each year Most children recover fast with full resolution of symptoms as headache dizziness or fatigue A few however develop life-threatening complications such as bleedings inaround the brain It can be difficult to swiftly and accurately identify these patients in the emergency department To aid in this task decision support tools has been developed
The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department
The main research question is
- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes
Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study as there is no intervention treatment group
The doctor or nurse managing the child will collect information on patient history signs and symptoms in the emergency department and management in an electronic case report form Information on how the recovery period is collected both from medical records 1 month after the emergency department visit as well as via electronic questionnaires sent to the guardian at 1 month 3 months and 4 months after the injury via e-mail andor text message Long-term outcome will also be examined 6 months
The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department
The main research question is
- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes
Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study as there is no intervention treatment group
The doctor or nurse managing the child will collect information on patient history signs and symptoms in the emergency department and management in an electronic case report form Information on how the recovery period is collected both from medical records 1 month after the emergency department visit as well as via electronic questionnaires sent to the guardian at 1 month 3 months and 4 months after the injury via e-mail andor text message Long-term outcome will also be examined 6 months
Detailed Description:
Design
This is a pragmatic prospective multicentre observational study of children presenting with mild or moderate traumatic brain injury TBI in a general or paediatric emergency department ED at hospitals in Scandinavia A complete data set for analysis including predictor variables and outcome data for the six guidelines included in the study will be registered SNC2016 PECARN CATCH CHALICE PREDICT NICE23 There are no interventions as the study is observational Attending physicians and nurses are instructed to manage children in accordance with the hospitals ordinary guidelines and follow local treatment traditions
Study setting and population
The study will be set in Sweden and Norway Hospitals with different trauma capacities will participate invitations are sent to units which on daily basis mange children with TBI in their department Efforts are made to establish a representative distribution in participating centres The coordinating centre is Halmstad Hospital in southern Sweden
Data registration and follow-up
Information on management in the emergency department including patient characteristics injury type and mechanism patient history clinical examination results and current medications will be prospectively documented in a web- based case-report form by the triage nurse andor physician on call
One month after trauma the local study coordinator will assess medical records and journals screening for outcome measures as well as CT findings when applicable A follow-up questionnaire will be sent to guardians 1 month 3 months and 4 months after the child s head injury via e-mail andor text message long-term follow up at 6 months Reminders will be re-sent if no answer is received primarily by e-mail and then twice by text message
All data will be registered in via web-based case report forms in Entermedic Entergate AB Pseudo-anonymized data will be extracted from database and imported to IBM SPSS Statistics software version 28 for statistical analysis
Biomarkers
A sub-study on patients with intermediate risk for intracranial injury and GCS 14-15 in selected study centres will explore biomarkers as predictors for intracranial injury Venous blood capillary blood and saliva sample is sampled from the patient in the ED after written informed consent Sampling is done within 12 hours from the time of the injury Analysis of biomarker S100B and others not yet specified will be analysed in batch at end of sub-study period
CT examinations
CT scans are analysed by a board-certified radiologist on the centre where the exam is performed
Statistics
The accuracy of the SNC guidelines to predict the primary endpoint will be assessed by 95 confidence intervals CI for sensitivity specificity likelihood ratio negative predictive value NPV and positive predictive value PPV Test performance for other internationally recognized clinical decision rules PECARN CATCH CHALICE NICE PREDICT will also be calculated both in application cohorts defined by each rule specific inclusion and exclusion criteria and in comparative cohorts minor head injury cohort all patients with GCS 13-15 all patient cohort When assessing CDRs other than SNC16 both rule specific endpoints and in-study defined endpoints will be tested Secondary endpoints will be assessed using the same methods Biomarker analysis results in ROC curves for sensitivity specificity and from these are specific cut-offs that maximize performance for negative predictive value ie to avoid unnecessary CT examinations andor admission derived
Sample size
The investigators aim to include 5300 children but not more than more than 4 years of active enrolment
Ethics
Ethical approval was granted from the Regional Ethical Review Board in Lund approval number 2017238 and Ethical Review Board in Norway approval number 1085 Informed verbal consent will be obtained and registered Patients data and social security number will be stored and handled accordingly to European Union General Data Protection Regulation GDPR 2016679 and applicable Swedish laws
A detailed protocol describing study methodology and statistical methods will be published before end of inclusion
This is a pragmatic prospective multicentre observational study of children presenting with mild or moderate traumatic brain injury TBI in a general or paediatric emergency department ED at hospitals in Scandinavia A complete data set for analysis including predictor variables and outcome data for the six guidelines included in the study will be registered SNC2016 PECARN CATCH CHALICE PREDICT NICE23 There are no interventions as the study is observational Attending physicians and nurses are instructed to manage children in accordance with the hospitals ordinary guidelines and follow local treatment traditions
Study setting and population
The study will be set in Sweden and Norway Hospitals with different trauma capacities will participate invitations are sent to units which on daily basis mange children with TBI in their department Efforts are made to establish a representative distribution in participating centres The coordinating centre is Halmstad Hospital in southern Sweden
Data registration and follow-up
Information on management in the emergency department including patient characteristics injury type and mechanism patient history clinical examination results and current medications will be prospectively documented in a web- based case-report form by the triage nurse andor physician on call
One month after trauma the local study coordinator will assess medical records and journals screening for outcome measures as well as CT findings when applicable A follow-up questionnaire will be sent to guardians 1 month 3 months and 4 months after the child s head injury via e-mail andor text message long-term follow up at 6 months Reminders will be re-sent if no answer is received primarily by e-mail and then twice by text message
All data will be registered in via web-based case report forms in Entermedic Entergate AB Pseudo-anonymized data will be extracted from database and imported to IBM SPSS Statistics software version 28 for statistical analysis
Biomarkers
A sub-study on patients with intermediate risk for intracranial injury and GCS 14-15 in selected study centres will explore biomarkers as predictors for intracranial injury Venous blood capillary blood and saliva sample is sampled from the patient in the ED after written informed consent Sampling is done within 12 hours from the time of the injury Analysis of biomarker S100B and others not yet specified will be analysed in batch at end of sub-study period
CT examinations
CT scans are analysed by a board-certified radiologist on the centre where the exam is performed
Statistics
The accuracy of the SNC guidelines to predict the primary endpoint will be assessed by 95 confidence intervals CI for sensitivity specificity likelihood ratio negative predictive value NPV and positive predictive value PPV Test performance for other internationally recognized clinical decision rules PECARN CATCH CHALICE NICE PREDICT will also be calculated both in application cohorts defined by each rule specific inclusion and exclusion criteria and in comparative cohorts minor head injury cohort all patients with GCS 13-15 all patient cohort When assessing CDRs other than SNC16 both rule specific endpoints and in-study defined endpoints will be tested Secondary endpoints will be assessed using the same methods Biomarker analysis results in ROC curves for sensitivity specificity and from these are specific cut-offs that maximize performance for negative predictive value ie to avoid unnecessary CT examinations andor admission derived
Sample size
The investigators aim to include 5300 children but not more than more than 4 years of active enrolment
Ethics
Ethical approval was granted from the Regional Ethical Review Board in Lund approval number 2017238 and Ethical Review Board in Norway approval number 1085 Informed verbal consent will be obtained and registered Patients data and social security number will be stored and handled accordingly to European Union General Data Protection Regulation GDPR 2016679 and applicable Swedish laws
A detailed protocol describing study methodology and statistical methods will be published before end of inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None