xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964764</url>
    </required_header>
    <id_info>
      <org_study_id>220871</org_study_id>
      <nct_id>NCT05964764</nct_id>
    </id_info>
    <brief_title>Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children</brief_title>
    <acronym>SHIPP</acronym>
    <official_title>A Pragmatic, Prospective, Multicentre Study for the Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Halmstad County Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Halmstad County Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Head injuries are common among children and adolescents, with many of them assessed in&#xD;
        emergency departments each year. Most children recover fast, with full resolution of symptoms&#xD;
        as headache, dizziness or fatigue. A few, however, develop life-threatening complications&#xD;
        (such as bleedings in/around the brain). It can be difficult to swiftly and accurately&#xD;
        identify these patients in the emergency department. To aid in this task, decision support&#xD;
        tools has been developed.&#xD;
  &#xD;
        The goal of this observational study is to evaluate a Scandinavian tool developed to aid in&#xD;
        management of children with head injuries seeking care in an emergency department.&#xD;
  &#xD;
        The main research question is:&#xD;
  &#xD;
        - Are the Scandinavian guidelines for management of mild and moderate head trauma in children&#xD;
        sensitive for patient-important outcomes?&#xD;
  &#xD;
        Patients will be given the same treatment and recommendations for their head injury no matter&#xD;
        if they participate or not in the study, as there is no intervention/ treatment group.&#xD;
  &#xD;
        The doctor or nurse managing the child will collect information on patient history, signs and&#xD;
        symptoms in the emergency department and management in an electronic case report form.&#xD;
        Information on how the recovery period is collected both from medical records &gt;1 month after&#xD;
        the emergency department visit, as well as via electronic questionnaires sent to the guardian&#xD;
        at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term&#xD;
        outcome will also be examined (&gt;6 months).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Design:&#xD;
  &#xD;
        This is a pragmatic, prospective, multicentre, observational study of children presenting&#xD;
        with mild or moderate traumatic brain injury (TBI) in a general or paediatric emergency&#xD;
        department (ED) at hospitals in Scandinavia. A complete data set for analysis including&#xD;
        predictor variables and outcome data for the six guidelines included in the study will be&#xD;
        registered (SNC2016, PECARN, CATCH, CHALICE, PREDICT, NICE23). There are no interventions as&#xD;
        the study is observational. Attending physicians and nurses are instructed to manage children&#xD;
        in accordance with the hospital's ordinary guidelines and follow local treatment traditions.&#xD;
  &#xD;
        Study setting and population:&#xD;
  &#xD;
        The study will be set in Sweden and Norway. Hospitals with different trauma capacities will&#xD;
        participate; invitations are sent to units which on daily basis mange children with TBI in&#xD;
        their department. Efforts are made to establish a representative distribution in&#xD;
        participating centres. The coordinating centre is Halmstad Hospital in southern Sweden.&#xD;
  &#xD;
        Data registration and follow-up:&#xD;
  &#xD;
        Information on management in the emergency department including patient characteristics,&#xD;
        injury type and mechanism, patient history, clinical examination results and current&#xD;
        medications will be prospectively documented in a web- based case-report form by the triage&#xD;
        nurse and/or physician on call.&#xD;
  &#xD;
        One month after trauma, the local study coordinator will assess medical records and journals,&#xD;
        screening for outcome measures as well as CT findings, when applicable. A follow-up&#xD;
        questionnaire will be sent to guardian(s) 1 month, 3 months and 4 months after the child ́s&#xD;
        head injury via e-mail and/or text message (long-term follow up at &gt;6 months). Reminders will&#xD;
        be re-sent if no answer is received, primarily by e-mail and then twice by text message.&#xD;
  &#xD;
        All data will be registered in via web-based case report forms in Entermedic (Entergate AB).&#xD;
        Pseudo-anonymized data will be extracted from database and imported to IBM SPSS® Statistics&#xD;
        software version 28 for statistical analysis.&#xD;
  &#xD;
        Biomarkers:&#xD;
  &#xD;
        A sub-study on patients with intermediate risk for intracranial injury and GCS 14-15, in&#xD;
        selected study centres will explore biomarkers as predictors for intracranial injury. Venous&#xD;
        blood, capillary blood and saliva sample is sampled from the patient in the ED after written&#xD;
        informed consent. Sampling is done within 12 hours from the time of the injury. Analysis of&#xD;
        biomarker S100B and others, not yet specified, will be analysed in batch at end of sub-study&#xD;
        period.&#xD;
  &#xD;
        CT examinations:&#xD;
  &#xD;
        CT scans are analysed by a board-certified radiologist on the centre where the exam is&#xD;
        performed.&#xD;
  &#xD;
        Statistics:&#xD;
  &#xD;
        The accuracy of the (SNC) guidelines to predict the primary endpoint will be assessed by 95%&#xD;
        confidence intervals (CI) for sensitivity, specificity, likelihood ratio, negative predictive&#xD;
        value (NPV) and positive predictive value (PPV). Test performance for other internationally&#xD;
        recognized clinical decision rules (PECARN, CATCH, CHALICE, NICE, PREDICT) will also be&#xD;
        calculated both in application cohorts (defined by each rule specific inclusion and exclusion&#xD;
        criteria) and in comparative cohorts (minor head injury cohort = all patients with GCS 13-15;&#xD;
        all patient cohort). When assessing CDRs other than SNC16, both rule specific endpoints and&#xD;
        in-study defined endpoints will be tested. Secondary endpoints will be assessed using the&#xD;
        same methods. Biomarker analysis results in ROC curves for sensitivity / specificity and from&#xD;
        these are specific cut-offs that maximize performance for negative predictive value (i.e., to&#xD;
        avoid unnecessary CT examinations and/or admission) derived.&#xD;
  &#xD;
        Sample size:&#xD;
  &#xD;
        The investigators aim to include 5,300 children, but not more than more than 4 years of&#xD;
        active enrolment.&#xD;
  &#xD;
        Ethics:&#xD;
  &#xD;
        Ethical approval was granted from the Regional Ethical Review Board in Lund (approval number&#xD;
        2017/238) and Ethical Review Board in Norway (approval number 1085). Informed verbal consent&#xD;
        will be obtained and registered. Patients' data and social security number will be stored and&#xD;
        handled accordingly to European Union General Data Protection Regulation (GDPR 2016/679) and&#xD;
        applicable Swedish laws.&#xD;
  &#xD;
        A detailed protocol describing study methodology and statistical methods will be published&#xD;
        before end of inclusion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2018</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>4 Months</target_duration>
    <primary_outcome>
      <measure>Number of participants with &quot;clinically important intracranial injury (CIII)&quot;</measure>
      <time_frame>Within 1 week of injury.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with death due to head injury</measure>
      <time_frame>Within one week; within 3 months.</time_frame>
      <description>Defined as death as consequence of the TBI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with neurosurgery due to TBI</measure>
      <time_frame>Within 1 week of injury.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with CT findings</measure>
      <time_frame>Within 1 week of injury.</time_frame>
      <description>Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with significant CT findings</measure>
      <time_frame>Within 1 week of injury.</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of specific biomarkers in serum and saliva</measure>
      <time_frame>Sampling at admission to the emergency department</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants admitted to in-hospital observation &gt; 2 days</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Admission to a hospital ward two (2) days or more due to TBI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants admitted to in-hospital observation</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Admission to a hospital ward due to TBI, irrespective of duration of observation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with extended &quot;clinical observation in ED&quot;</measure>
      <time_frame>Within the first day (24 hours) of injury</time_frame>
      <description>Prolonged clinical observation in ED due to TBI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of clinical observation</measure>
      <time_frame>Within 1 week of injury.</time_frame>
      <description>Duration of clinical observation (time in ED or time in ED and in-hospital ward)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants intubated due to TBI</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Endotracheal intubation due to TBI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of intubation due to TBI</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Duration of intubation categorised as &lt;6h, 6-12 h, 13-24h, 25-48 h, 49h-1 week and &gt;1 week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants referred for cranial CT (cCT) due to head injury.</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Referred for cCT due to head injury</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants referred for a follow up (re-)cCT due to clinical deterioration.</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Referred for re-cCT due to clinical deterioration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants referred for a cCT due to clinical deterioration during prolonged observation (in ED or on ward).</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Referred for (primary) cCT due to clinical deterioration during prolonged clinical observation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with need for sedation or intubation during cCT exam</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>All ages and stratified 0-4 years, 5-14 years and &gt;14 years. Sedation is defined as positive if participant has received a sedative agent (for example propofol or midazolam) during CT scan.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with presence of outcome as defined by CATCH-rule (&quot;need for neurological intervention&quot; or &quot;brain injury on CT&quot; )</measure>
      <time_frame>Within one week from trauma</time_frame>
      <description>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.&#xD;
  Brain injury on CT defined as any acute intracranial finding revealed on CT that was attributable to acute injury, including closed depressed skull fracture.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with presence of outcome as defined by PECARN-rule (&quot;clinically important TBI&quot;).</measure>
      <time_frame>Within one week from trauma</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with presence of outcome as defined by CHALICE-rule (&quot;clinically significant intracranial injury&quot; or &quot;presence of skull fracture&quot; or &quot;admission to hospital&quot;).</measure>
      <time_frame>Within one week from trauma</time_frame>
      <description>Clinically significant intracranial injury is &quot;defined as death as a result of head injury, requirement for neurosurgical intervention, or marked abnormality on CT.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with presence of outcome as defined by PREDICT-rule (&quot;clinically important intracranial injury in need for intervention&quot;).</measure>
      <time_frame>Within one week from trauma</time_frame>
      <description>Clinically important intracranial injury in need for intervention is defined as neurosurgery and/or intensive care due to TBI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with presence of outcome as defined by NICE23-rule (&quot;clinically important traumatic brain injury&quot;)</measure>
      <time_frame>Within one week from trauma</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants reassessed or readmitted due to TBI</measure>
      <time_frame>Within four weeks from trauma</time_frame>
      <description>Reassessed and sent home from ED, or admitted from ED after reassessment due to prior TBI.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants transported to other hospital due to TBI</measure>
      <time_frame>Within 3 months from injury</time_frame>
      <description>Transport to other hospital due to TBI, irrespective of cause or way of transportation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to full recovery</measure>
      <time_frame>&lt;1 week, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, not recovered at 3 months</time_frame>
      <description>Time to full recovery from TBI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinicial utility SNC16 rule</measure>
      <time_frame>At admission to the emergency department.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Participant rating on GOS-E PEDS Score</measure>
      <time_frame>3 months after injury</time_frame>
      <description>Clinical outcome according to GOS-E PEDS (paediatric Glasgow Outcome Scale extended version), score 1-8 (higher score indicate worse outcome), assessed by parent.</description>
    </other_outcome>
    <other_outcome>
      <measure>Participant rating on Post Concussion Symptom Inventory - Parent (PCSI-P) assessment</measure>
      <time_frame>3 months after injury.</time_frame>
      <description>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).</description>
    </other_outcome>
    <other_outcome>
      <measure>Participant rating on Mental Fatigue Scale</measure>
      <time_frame>1 month and 4 months after injury.</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Long-term outcome</measure>
      <time_frame>5 years post TBI</time_frame>
      <description>Assessment of remaining post concussive symptoms at 5 years after TBI. Assessed by GOS-E PEDS, PCSI-P and Mental Fatigue Scale.</description>
    </other_outcome>
    <enrollment type="Anticipated">5300</enrollment>
    <condition>Brain Injuries, Traumatic</condition>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        In a subgroup of patients (target n=1000) a blood and saliva sample for postponed analysis of&#xD;
        biomarkers in TBI will be obtained after written informed consent.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Target population is children in Scandinavia with recent minor and moderate head trauma&#xD;
          seeking care on emergency departments within participating in study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years.&#xD;
  &#xD;
            -  Minor and moderate blunt head trauma (GCS 9 - 15) seeking medical assessment in an&#xD;
               emergency department at a study hospital in Sweden or Norway.&#xD;
  &#xD;
            -  Within 24 hours of trauma.&#xD;
  &#xD;
            -  Informed oral consent from one guardian, and child if older than 14 years old, after&#xD;
               receiving oral and written information about study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient and/or guardian does not wish to participate in the study.&#xD;
  &#xD;
            -  Patient included in other study that may affect the management/treatment in the&#xD;
               emergency department.&#xD;
  &#xD;
            -  Penetrating head injury (as those will always receive a CT scan).&#xD;
  &#xD;
            -  Suspected child abuse / non-accidental trauma (NAT) denoted as suspected child abuse&#xD;
               where the social services are informed (as they will always receive a CT scan).&#xD;
  &#xD;
            -  The patient is not a citizen in the participating country and hence difficult to&#xD;
               follow up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Johan Undén, MD, PhD.</last_name>
      <role>Study Chair</role>
      <affiliation>Region Halland and Lund University, Sweden</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fredrik Wickbom, MD</last_name>
      <phone>004635131000</phone>
      <email>fredrik.wickbom@regionhalland.se</email>
    </overall_contact>
    <location>
      <facility>
        <name>Haukeland Universitetssjukehus</name>
        <address>
          <city>Haukeland</city>
          <country>Norway</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aqeel Chaudhry, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Alingsås Lasarett</name>
        <address>
          <city>Alingsås</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hanna Farahnoosh, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mälarsjukhuset i Eskilsstuna</name>
        <address>
          <city>Eskilstuna</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Drottning Silvias Barnsjukhus</name>
        <address>
          <city>Göteborg</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sarah Thornberg, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Halland Hospital Halmstad</name>
        <address>
          <city>Halmstad</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fredrik Wickbom, MD</last_name>
        <phone>004635131000</phone>
        <email>fredrik.wickbom@regionhalland.se</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Länssjukhuset Ryhov</name>
        <address>
          <city>Jönköping</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Lasarettet i Ljungby</name>
        <address>
          <city>Ljungby</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Malin Johansson, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Skåne University Hospital, Lund</name>
        <address>
          <city>Lund</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jorge Sotoca Fernandez, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Skånes Universitetssjukhus Malmö</name>
        <address>
          <city>Malmö</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jorge Sotoca Fernandez, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mora Lasarett</name>
        <address>
          <city>Mora</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anders Santoft, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Astrid Lindgren Childrens Hospital, Solna</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristofer Kjellröier, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Norra Älvsborgs Länssjukhus</name>
        <address>
          <city>Trollhättan</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Completed</status>
    </location>
    <location>
      <facility>
        <name>Norrland University Hospital, NUS</name>
        <address>
          <city>Umeå</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Beatrice Magnusson, MD, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Halland Hospital Varberg</name>
        <address>
          <city>Varberg</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rasmus Silfver, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ystad Lasarett</name>
        <address>
          <city>Ystad</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rachel Keeling, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Örebro Universitetssjukhus</name>
        <address>
          <city>Örebro</city>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Terminated</status>
    </location>
    <location_countries>
      <country>Norway</country>
      <country>Sweden</country>
    </location_countries>
    <link>
      <url>http://www.shipp.se/</url>
      <description>Study information page</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Halmstad County Hospital</investigator_affiliation>
      <investigator_full_name>Fredrik Wickbom</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
      <mesh_term>Craniocerebral Trauma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Sharing of de-identified data for all primary and secondary outcome measures will be considered on individual basis after main and secondary analysis has been completed.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be available on reasonable request up to 10 years after study completion.</ipd_time_frame>
      <ipd_access_criteria>Investigators whose proposed use of the data has been approved by the study review committee and sharing of requested data is permitted by Swedish and European law.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964764
  org study id: 220871
  nct id: NCT05964764
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of participants with "clinically important intracranial injury (CIII)"
  time frame: Within 1 week of injury.
  description: 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.
  measure: Number of participants with death due to head injury
  time frame: Within one week; within 3 months.
  description: Defined as death as consequence of the TBI
  measure: Number of participants with neurosurgery due to TBI
  time frame: Within 1 week of injury.
  description: 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.
  measure: Number of participants with CT findings
  time frame: Within 1 week of injury.
  description: Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage.
  measure: Number of participants with significant CT findings
  time frame: Within 1 week of injury.
  description: 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
  measure: Concentration of specific biomarkers in serum and saliva
  time frame: Sampling at admission to the emergency department
  description: 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.
  measure: Number of participants admitted to in-hospital observation > 2 days
  time frame: Within 3 months from injury
  description: Admission to a hospital ward two (2) days or more due to TBI.
  measure: Number of participants admitted to in-hospital observation
  time frame: Within 3 months from injury
  description: Admission to a hospital ward due to TBI, irrespective of duration of observation
  measure: Number of participants with extended "clinical observation in ED"
  time frame: Within the first day (24 hours) of injury
  description: Prolonged clinical observation in ED due to TBI
  measure: Duration of clinical observation
  time frame: Within 1 week of injury.
  description: Duration of clinical observation (time in ED or time in ED and in-hospital ward)
  measure: Number of participants intubated due to TBI
  time frame: Within 3 months from injury
  description: Endotracheal intubation due to TBI
  measure: Duration of intubation due to TBI
  time frame: Within 3 months from injury
  description: Duration of intubation categorised as <6h, 6-12 h, 13-24h, 25-48 h, 49h-1 week and >1 week.
  measure: Number of participants referred for cranial CT (cCT) due to head injury.
  time frame: Within 3 months from injury
  description: Referred for cCT due to head injury
  measure: Number of participants referred for a follow up (re-)cCT due to clinical deterioration.
  time frame: Within 3 months from injury
  description: Referred for re-cCT due to clinical deterioration.
  measure: Number of participants referred for a cCT due to clinical deterioration during prolonged observation (in ED or on ward).
  time frame: Within 3 months from injury
  description: Referred for (primary) cCT due to clinical deterioration during prolonged clinical observation.
  measure: Number of participants with need for sedation or intubation during cCT exam
  time frame: Within 3 months from injury
  description: 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.
  measure: Number of participants with presence of outcome as defined by CATCH-rule ("need for neurological intervention" or "brain injury on CT" )
  time frame: Within one week from trauma
  description: 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.
  measure: Number of participants with presence of outcome as defined by PECARN-rule ("clinically important TBI").
  time frame: Within one week from trauma
  description: 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.
  measure: 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").
  time frame: Within one week from trauma
  description: Clinically significant intracranial injury is "defined as death as a result of head injury, requirement for neurosurgical intervention, or marked abnormality on CT.
  measure: Number of participants with presence of outcome as defined by PREDICT-rule ("clinically important intracranial injury in need for intervention").
  time frame: Within one week from trauma
  description: Clinically important intracranial injury in need for intervention is defined as neurosurgery and/or intensive care due to TBI.
  measure: Number of participants with presence of outcome as defined by NICE23-rule ("clinically important traumatic brain injury")
  time frame: Within one week from trauma
  description: 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.
  measure: Number of participants reassessed or readmitted due to TBI
  time frame: Within four weeks from trauma
  description: Reassessed and sent home from ED, or admitted from ED after reassessment due to prior TBI.
  measure: Number of participants transported to other hospital due to TBI
  time frame: Within 3 months from injury
  description: Transport to other hospital due to TBI, irrespective of cause or way of transportation.
  measure: Time to full recovery
  time frame: <1 week, 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, not recovered at 3 months
  description: Time to full recovery from TBI
  measure: Clinicial utility SNC16 rule
  time frame: At admission to the emergency department.
  description: 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.
  measure: Participant rating on GOS-E PEDS Score
  time frame: 3 months after injury
  description: Clinical outcome according to GOS-E PEDS (paediatric Glasgow Outcome Scale extended version), score 1-8 (higher score indicate worse outcome), assessed by parent.
  measure: Participant rating on Post Concussion Symptom Inventory - Parent (PCSI-P) assessment
  time frame: 3 months after injury.
  description: 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).
  measure: Participant rating on Mental Fatigue Scale
  time frame: 1 month and 4 months after injury.
  description: 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.
  measure: Long-term outcome
  time frame: 5 years post TBI
  description: Assessment of remaining post concussive symptoms at 5 years after TBI. Assessed by GOS-E PEDS, PCSI-P and Mental Fatigue Scale.
  In a subgroup of patients (target n=1000) a blood and saliva sample for postponed analysis of
        biomarkers in TBI will be obtained after written informed consent.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 17 Years
  healthy volunteers: No
  last name: Johan Undén, MD, PhD.
  role: Study Chair
  affiliation: Region Halland and Lund University, Sweden
  last name: Fredrik Wickbom, MD
  phone: 004635131000
  email: fredrik.wickbom@regionhalland.se
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Completed
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Terminated
  country: Norway
  country: Sweden
  url: http://www.shipp.se/
  description: Study information page
  responsible party type: Principal Investigator
  investigator affiliation: Halmstad County Hospital
  investigator full name: Fredrik Wickbom
  investigator title: Principal Investigator
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Craniocerebral Trauma
  sharing ipd: Yes
  ipd description: Sharing of de-identified data for all primary and secondary outcome measures will be considered on individual basis after main and secondary analysis has been completed.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: Data will be available on reasonable request up to 10 years after study completion.
  ipd access criteria: Investigators whose proposed use of the data has been approved by the study review committee and sharing of requested data is permitted by Swedish and European law.