‘CHIP REfinement STudy (CREST)’. Prospective refinement study of the CHIP (CT in Head Injury Patients) prediction rule for patients with minor head injury.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22644

Enrollment

2703

Registered

2015-08-20

Start date

2016-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minor head injury mild Traumatic Brain injury traumatic Intracranial Haemorrhage Licht Traumatisch Hoofd/Hersenletsel

Interventions

CT scan of the head S100B blood sample

Eligibility

Inclusion criteria

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 Vomiting 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

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

Design outcomes

Primary

Measure	Time frame
•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

Measure	Time frame
• 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.	—

Measure

Time frame

• 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.

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Contacts

Public ContactCrispijn van den Brand

Koningsplein 17

brachr@mchaaglanden.nl0651728689

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)