Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

Brain Injuries, Traumatic Clinical Trial

— SHIPP  

Official title:

A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964764
• Other study ID #: 220871
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: Halmstad County Hospital
• Contact: Fredrik Wickbom, MD
• Phone: 004635131000
• Email: fredrik.wickbom[@]regionhalland.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 in/around 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 and/or text message. Long-term outcome will also be examined (>6 months).

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 hospital's 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 and/or 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 guardian(s) 1 month, 3 months and 4 months after the child ́s head injury via e-mail and/or 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 (i.e., to avoid unnecessary CT examinations and/or admission) derived.

Sample size:

The investigators aim to include 5,300 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 2017/238) 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 2016/679) and applicable Swedish laws.

A detailed protocol describing study methodology and statistical methods will be published before end of inclusion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5300
• Est. completion date: December 31, 2029
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Age <18 years.

• Minor and moderate blunt head trauma (GCS 9 - 15) seeking medical assessment in an emergency department at a study hospital in Sweden or Norway.

• Within 24 hours of trauma.

• Informed oral consent from one guardian, and child if older than 14 years old, after receiving oral and written information about study.

Exclusion Criteria:

• Patient and/or guardian does not wish to participate in the study.

• Patient included in other study that may affect the management/treatment in the emergency department.

• Penetrating head injury (as those will always receive a CT scan).

• Suspected child abuse / non-accidental trauma (NAT) denoted as suspected child abuse where the social services are informed (as they will always receive a CT scan).

• The patient is not a citizen in the participating country and hence difficult to follow up.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma

Locations

Country	Name	City	State
Norway	Haukeland Universitetssjukehus	Haukeland
Sweden	Alingsås Lasarett	Alingsås
Sweden	Mälarsjukhuset i Eskilsstuna	Eskilstuna
Sweden	Drottning Silvias Barnsjukhus	Göteborg
Sweden	Halland Hospital Halmstad	Halmstad
Sweden	Länssjukhuset Ryhov	Jönköping
Sweden	Lasarettet i Ljungby	Ljungby
Sweden	Skåne University Hospital, Lund	Lund
Sweden	Skånes Universitetssjukhus Malmö	Malmö
Sweden	Mora Lasarett	Mora
Sweden	Örebro Universitetssjukhus	Örebro
Sweden	Astrid Lindgren Childrens Hospital, Solna	Stockholm
Sweden	Norra Älvsborgs Länssjukhus	Trollhättan
Sweden	Norrland University Hospital, NUS	Umeå
Sweden	Halland Hospital Varberg	Varberg
Sweden	Ystad Lasarett	Ystad

Sponsors (1)

Lead Sponsor	Collaborator
Halmstad County Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant rating on GOS-E PEDS Score	Clinical outcome according to GOS-E PEDS (paediatric Glasgow Outcome Scale extended version), score 1-8 (higher score indicate worse outcome), assessed by parent.	3 months after injury
Other	Participant rating on Post Concussion Symptom Inventory - Parent (PCSI-P) assessment	Clinical outcome on PCSI-P assessed by parent on a 20-item scale. Each item assessed on a 7-point scale (0 = not a problem, 6 = severe problem).	3 months after injury.
Other	Participant rating on Mental Fatigue Scale	Clinical outcome on modified Mental Fatigue Scale assessed by parent. 15 items assessed 0 - 2/3. Higher value indicates a higher degree of severity. One question on variation of symptoms over day. One question on pre-injury status.	1 month and 4 months after injury.
Other	Long-term outcome	Assessment of remaining post concussive symptoms at 5 years after TBI. Assessed by GOS-E PEDS, PCSI-P and Mental Fatigue Scale.	5 years post TBI
Primary	Number of participants with "clinically important intracranial injury (CIII)"	Defined as a composite variable of death, neurosurgery, admission to hospital ward two (2) days or more due to head injury or intubation one (1) day or more due to pathological traumatic CT findings.	Within 1 week of injury.
Secondary	Number of participants with death due to head injury	Defined as death as consequence of the TBI	Within one week; within 3 months.
Secondary	Number of participants with neurosurgery due to TBI	Defined as need for any neurosurgical procedure or intervention, including sedation and intubation with controlled ventilation for non-surgical injuries such as diffuse axonal injury.	Within 1 week of injury.
Secondary	Number of participants with CT findings	Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage.	Within 1 week of injury.
Secondary	Number of participants with significant CT findings	Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage, but not including undislocated skull fractures	Within 1 week of injury.
Secondary	Concentration of specific biomarkers in serum and saliva	Biomarker concentration (S-100B, GFAP, UCH-L1, NSE, tau, NF(H and L), H-FABP, SNTF, MBP, miRNAs, IL-10, BTP, SBDP145, MMP9, HGF, IL-6, OPN, SAA, SICAM, leptin, copeptin, fibrinogen, d-dimer, ICAM, VCAM, IL-12, eotaxin, TNFR2 in a group of patients with TBI and GCS 14-15 in ED.	Sampling at admission to the emergency department
Secondary	Number of participants admitted to in-hospital observation > 2 days	Admission to a hospital ward two (2) days or more due to TBI.	Within 3 months from injury
Secondary	Number of participants admitted to in-hospital observation	Admission to a hospital ward due to TBI, irrespective of duration of observation	Within 3 months from injury
Secondary	Number of participants with extended "clinical observation in ED"	Prolonged clinical observation in ED due to TBI	Within the first day (24 hours) of injury
Secondary	Duration of clinical observation	Duration of clinical observation (time in ED or time in ED and in-hospital ward)	Within 1 week of injury.
Secondary	Number of participants intubated due to TBI	Endotracheal intubation due to TBI	Within 3 months from injury
Secondary	Duration of intubation due to TBI	Duration of intubation categorised as <6h, 6-12 h, 13-24h, 25-48 h, 49h-1 week and >1 week.	Within 3 months from injury
Secondary	Number of participants referred for cranial CT (cCT) due to head injury.	Referred for cCT due to head injury	Within 3 months from injury
Secondary	Number of participants referred for a follow up (re-)cCT due to clinical deterioration.	Referred for re-cCT due to clinical deterioration.	Within 3 months from injury
Secondary	Number of participants referred for a cCT due to clinical deterioration during prolonged observation (in ED or on ward).	Referred for (primary) cCT due to clinical deterioration during prolonged clinical observation.	Within 3 months from injury
Secondary	Number of participants with need for sedation or intubation during cCT exam	All ages and stratified 0-4 years, 5-14 years and >14 years. Sedation is defined as positive if participant has received a sedative agent (for example propofol or midazolam) during CT scan.	Within 3 months from injury
Secondary	Number of participants with presence of outcome as defined by CATCH-rule ("need for neurological intervention" or "brain injury on CT" )	Need for neurological intervention is defined as either death within 7 days secondary to the head injury or need for any of the following procedures within 7 days: craniotomy, elevation of skull fracture, monitoring of intracranial pressure, or insertion of an endotracheal tube for the management of head injury.; Brain injury on CT defined as any acute intracranial finding revealed on CT that was attributable to acute injury, including closed depressed skull fracture.	Within one week from trauma
Secondary	Number of participants with presence of outcome as defined by PECARN-rule ("clinically important TBI").	Clinically important TBI is defined as death from TBI, neurosurgical intervention for TBI (intracranial pressure monitoring, elevation of depressed skull fracture, ventriculostomy, haematoma evacuation, lobectomy, tissue debridement, dura repair, or other), intubation of more than 24 h for TBI or hospital admission of 2 nights or more for TBI in association with TBI on CT.	Within one week from trauma
Secondary	Number of participants with presence of outcome as defined by CHALICE-rule ("clinically significant intracranial injury" or "presence of skull fracture" or "admission to hospital").	Clinically significant intracranial injury is "defined as death as a result of head injury, requirement for neurosurgical intervention, or marked abnormality on CT.	Within one week from trauma
Secondary	Number of participants with presence of outcome as defined by PREDICT-rule ("clinically important intracranial injury in need for intervention").	Clinically important intracranial injury in need for intervention is defined as neurosurgery and/or intensive care due to TBI.	Within one week from trauma
Secondary	Number of participants with presence of outcome as defined by NICE23-rule ("clinically important traumatic brain injury")	Clinically important traumatic brain injury is assumed to be the same as in PECRAN, hence defined as death from TBI, neurosurgical intervention for TBI (intracranial pressure monitoring, elevation of depressed skull fracture, ventriculostomy, haematoma evacuation, lobectomy, tissue debridement, dura repair, or other), intubation of more than 24 h for TBI or hospital admission of 2 nights or more for TBI in association with TBI on CT.	Within one week from trauma
Secondary	Number of participants reassessed or readmitted due to TBI	Reassessed and sent home from ED, or admitted from ED after reassessment due to prior TBI.	Within four weeks from trauma
Secondary	Number of participants transported to other hospital due to TBI	Transport to other hospital due to TBI, irrespective of cause or way of transportation.	Within 3 months from injury
Secondary	Time to full recovery	Time to full recovery from TBI	<1 week, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, not recovered at 3 months
Secondary	Clinicial utility SNC16 rule	Experienced utility of the SNC16-rule when applied hypothetically on the participating child with TBI, by the managing doctor. Assessed on a 7-step Likert scale.	At admission to the emergency department.

External Links

•   Study information page