|- candidate number||22776|
|- NTR Number||NTR5409|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-aug-2015|
|- Secondary IDs||VOLGT |
|- Public Title||‘CHIP REfinement STudy (CREST)’. Prospective refinement study of the CHIP (CT in Head Injury Patients) prediction rule for patients with minor head injury.|
|- Scientific Title||‘CHIP REfinement STudy (CREST)’. Prospective refinement study of the CHIP (CT in Head Injury Patients) prediction rule for patients with minor head injury.|
|- hypothesis||Refinement of the CHIP prediction rule will lead to a more efficient use of head CT in patients with minor head injury|
|- Healt Condition(s) or Problem(s) studied||Mild traumatic brain injury|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:|
• Patients 16 years and older and
• Blunt trauma to the head in the last 24 hours and
• Fulfill the definition of minor head/brain injury as defined in the Dutch guideline:
o Glasgow Coma Scale (GCS) of 13-15
o In case of posttraumatic loss of consciousness: no more than 30 minutes
o In case of posttraumatic anterograde amnesia: no more than 24 hours
• A head CT is made to rule out traumatic intracranial lesions (according to current hospital guidelines)
• Have at least one risk factor (minor or major criteria in CBO guideline):
o Pedestrian or cyclist versus vehicle
o Ejected from motor vehicle
o Signs of skull fracture
o GCS score <15 on presentation
o Posttraumatic amnesia
o GCS deterioration
o Coumarin or heparin (LMWH) use
o Posttraumatic seizure
o Age ≥ 40
o Fall from any elevation
o Focal neurologic deficit
o Loss of consciousness
o Persistent anterograde amnesia
o Visible injury to the head, excluding the face (without signs of fracture)
o Suspicion of intracranial injury after focal “high impact” injury
o Use of antiplatelet drugs
o Use of New/Direct Oral Anticoagulants NOAC’s/DOAC’s
o Signs of intoxication with alcohol or drugs
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
• Contraindications for CT scanning
• Patients with concurrent injuries that preclude CT scanning
• Only superficial injury to the face. The face is defined as the area of the head from (including) the eyebrows to the chin (including).
• No head CT-scan is made
• Patients transferred from other hospitals
• Consecutive ED visit for the same trauma
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2016|
|- planned closingdate||1-jan-2018|
|- Target number of participants||2703|
|- Interventions||CT scan of the head|
S100B blood sample
|- Primary outcome||• Refine/modify the CHIP prediction rule to enhance efficiency and determine the sensitivity, specificity and predictive values of the modified CHIP prediction rule for both traumatic intracranial lesions on CT scan and neurosurgical lesions on CT scan. |
|- Secondary outcome||• To prospectively validate the CHIP prediction rule for the use of head CT in patients with minor head injury.
This entails determining sensitivity, specificity, and predictive values in predicting the presence versus absence of a traumatic intracranial lesion on the CT scan.|
• Determine sensitivity, specificity, and predictive values of the original CHIP prediction rule in predicting the presence of a traumatic intracranial lesion on the CT scan that necessitates neurosurgical intervention within 30 days after trauma.
• Determine which of the collected potential risk factors are independent risk factor for traumatic intracranial lesions on CT scan.
• For self referred patients at the ED: determine the sensitivity, specificity and predictive values of the referral criteria as defined by the Netherlands General Practitioners society (NHG) for both traumatic intracranial lesions on CT scan and neurosurgical intervention.
• Determine if any admitted patients deteriorate during admission (deteriorated GCS; new/progression of traumatic findings on head CT; neurosurgical intervention).
• Determine if any patients return with traumatic intracranial lesions that were not identified on the initial CT-head and determine the interval between trauma and the initial CT-head.
• For patients with traumatic intracranial lesions on CT the Extended Glasgow Outcome Scale (GOSE) at 3 months will be assessed.
• Determine if the protein S100B is a reliable marker for intracranial findings on CT in patients with minor head injury. (substudy only in MCH-Bronovo)
This entails determining sensitivity, specificity, and predictive values in predicting the presence versus absence of a traumatic intracranial lesion on the CT scan.
|- Timepoints||Not applicable|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Crispijn van den Brand|
|- CONTACT for SCIENTIFIC QUERIES|| Crispijn van den Brand|
|- Sponsor/Initiator ||Medical Center Haaglanden|
(Source(s) of Monetary or Material Support)
|St Jacobus Stichting, The Hague|
|- Brief summary||Rationale: Intracranial complications after minor head injury are infrequent (<10%), but are potentially life threatening and occasionally (<1%) require neurosurgical intervention. Computed tomography (CT) is the imaging modality of choice for fast and reliable diagnosis of intracranial complications of head injury. To enhance the selective use of CT in minor head trauma patients and to limit practice variation several decision rules and guidelines for minor head injury have been developed. In The Netherlands the CBO guideline, which is based on the CT in Head Injury Patients (CHIP) prediction rule, is generally used. This prediction rule is applicable to (almost) all adult patients with blunt head injury. In the derivation study the CHIP prediction rule had a sensitivity of 100% for neurosurgical intervention and a sensitivity of 94-96% for intracranial traumatic CT findings. To date no validation study has been done.
A recent study however showed that both CT-ratio and hospitalization increased after introduction of the CBO guideline. Another concern about the CHIP prediction rule is that it has not been externally validated and not tested in non-level I trauma centers or non-university hospitals. The Hypothesis of the CREST study are:
1. Refinement of the CHIP prediction rule will lead to a more efficient use of head CT in patients with minor head injury
2. The CHIP prediction rule is a safe prediction tool in regard to predicting the absence of intracranial lesions on CT scan after minor head injury.
Objective: Primary objective of the CREST is to refine the CHIP prediction rule for the use of head CT in patients with minor head injury.
Study design: Multicenter prospective noninterventional cohort study
Study population: Patients 16 years and older with minor head injury
Intervention (if applicable): Not applicable
Main study parameters/endpoints: Any intracranial traumatic lesion on CT scanning is considered a positive outcome.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a noninterventional study no specific risks are associated with participation. CT-scans will be made according to the CBO/CHIP guideline, this is currently standard care. No additional visits are needed. Only patients with intracranial traumatic findings on CT will be asked permission for telephonic contact after three months to fill out a short questionnaire (GOSE questionnaire)
|- Main changes (audit trail)|
|- RECORD||20-aug-2015 - 28-okt-2015|