Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06069674
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-05-19
Brief Title:
Use of Cerebral Biomarkers in Minor Traumatic Brain Injury in the Emergency Unit
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Use of Cerebral Biomarkers in Minor Traumatic Brain Injury in the Emergency Unit
Status:
RECRUITING
Status Verified Date:
2023-10
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:
CerBio-mTBI
Brief Summary:
The use of serum biomarkers in the setting of the emergency department ED has been well characterized over the years as an adjunctive tool for the clinician in the setting of complex decision making In this regard the serum dosage of glial fibrillary acidic protein GFAP and ubiquitin C-terminal hydrolase L1 UCH-L1 has been evaluated in a series of successful multicenter prospective studies as a potentially useful marker of respectively glial and neuronal damage in the setting of mild traumatic brain injury mTBI which is defined as a brain injury concussion secondary to trauma with a GCS Glasgow coma scale score of 13-15 It seems that both markers are detectable in serum less than 1 hour after the traumatic event with highest levels appearing at around 2 hours and are capable of distinguishing between patients with traumatic brain injury from those without acute brain injury after trauma Furthermore they seem to possess a high negative predictive value for detection of intracranial injuries at head CT-scan as well as the need of neurosurgical intervention after head trauma
Mild traumatic brain injury is one of the most frequent chief-complaints for patients presenting to emergency departments worldwide At present head CT scan is the gold standard diagnostic test for the identification of potentially life-threatening intra-cranial injuries Although effective in the identification of serious lesions which might require neurosurgical intervention or in-hospital prolonged observation the extensive use of head CT scan in mTBI has been questioned due to the potential risks related to radiation exposure as well as unnecessary deployment of ED resources and increased costs considering that the prevalence of CT-detected intra-cranial injury in mTBI is around 5-10
For this reason a number of international clinical guidelines suggest several Clinical Decision Rules CDR and algorithms to guide the clinician in the correct management of these patients in particular in the difficult feat of identifying those patients who dont need to perform neuroradiological evaluation CT scan or MRI in the setting of the ED without the risk to overlook potentially fatal brain injuries
The adjunctive role of these biomarkers has been well characterized in the setting of mTBI It seems they correlate well with neurological damage as well as with the presence of CT abnormalities and it seems that they might perform better than clinical evaluation alone
Nonetheless according to current international guidelines and several systematic reviews and meta-analysis patients who present with mTBI and risk factors for bleeding and delayed bleeding such as known coagulopathy patients on blood thinners or advanced age need to perform CT scan plus clinical observation or even serial CT scans when the risk of delayed bleeding is considered to be high according to clinical evaluation of the ED physician and according to local standard-of-care and clinical practice The execution of serial CT scans can be time consuming expensive for the health-care services and might pose a significant radiological risk for patients furthermore this risk might be unjustified considering that the prevalence of development of late intra-cranial bleeding in patients with risk factors who perform a second head CT scan during observation in the ED is considered to be around 2
Nonetheless in this category of patients clinical observation and the repetition of a second head CT scan is felt to be the safest course of action for patients in order not to overlook potentially fatal injuries
Ideally a clinical decision algorithm which takes into consideration a serum biomarker with a high negative predictive value for brain injury might aid the clinician to reduce the number of useless CT scans therefore reducing the observation time in the ED as well as the exposure to ionizing radiations for the patients while not increasing the number of missed delayed bleedings
At present the role of GFAP and UCH-L1 in the risk stratification of patients with risk factors for delayed cerebral bleeding after mTBI has not been evaluated yet
Mild traumatic brain injury is one of the most frequent chief-complaints for patients presenting to emergency departments worldwide At present head CT scan is the gold standard diagnostic test for the identification of potentially life-threatening intra-cranial injuries Although effective in the identification of serious lesions which might require neurosurgical intervention or in-hospital prolonged observation the extensive use of head CT scan in mTBI has been questioned due to the potential risks related to radiation exposure as well as unnecessary deployment of ED resources and increased costs considering that the prevalence of CT-detected intra-cranial injury in mTBI is around 5-10
For this reason a number of international clinical guidelines suggest several Clinical Decision Rules CDR and algorithms to guide the clinician in the correct management of these patients in particular in the difficult feat of identifying those patients who dont need to perform neuroradiological evaluation CT scan or MRI in the setting of the ED without the risk to overlook potentially fatal brain injuries
The adjunctive role of these biomarkers has been well characterized in the setting of mTBI It seems they correlate well with neurological damage as well as with the presence of CT abnormalities and it seems that they might perform better than clinical evaluation alone
Nonetheless according to current international guidelines and several systematic reviews and meta-analysis patients who present with mTBI and risk factors for bleeding and delayed bleeding such as known coagulopathy patients on blood thinners or advanced age need to perform CT scan plus clinical observation or even serial CT scans when the risk of delayed bleeding is considered to be high according to clinical evaluation of the ED physician and according to local standard-of-care and clinical practice The execution of serial CT scans can be time consuming expensive for the health-care services and might pose a significant radiological risk for patients furthermore this risk might be unjustified considering that the prevalence of development of late intra-cranial bleeding in patients with risk factors who perform a second head CT scan during observation in the ED is considered to be around 2
Nonetheless in this category of patients clinical observation and the repetition of a second head CT scan is felt to be the safest course of action for patients in order not to overlook potentially fatal injuries
Ideally a clinical decision algorithm which takes into consideration a serum biomarker with a high negative predictive value for brain injury might aid the clinician to reduce the number of useless CT scans therefore reducing the observation time in the ED as well as the exposure to ionizing radiations for the patients while not increasing the number of missed delayed bleedings
At present the role of GFAP and UCH-L1 in the risk stratification of patients with risk factors for delayed cerebral bleeding after mTBI has not been evaluated yet
Detailed Description:
Study design Ambispective observational study without drug nor device
Population The study population will include all non-pregnant patients who are 18 yo and meet the pre-specified inclusion criteria We will enroll patients who present to our ED with mTBI and who undergo a venous blood sample and serial brain CT scans as part of their standard emergency care according to the present intra-hospital guidelines and the choice of the attending physician
Study duration The duration of the study will be of 18 months starting from the approval of the present protocol by the local Ethics Committee of Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome Retrospectively enrolled patients will cover the period from October 2022 up to approval of the protocol date in which the prospective enrollment will start The enrolment phase will last 12 months whilst the following 6 will be dedicated to data extraction statistical analysis and scientific reporting
Variables and procedures Retrospective data will be retrieved from our healthcare electronic system for all patients who presented to the ED with the inclusion criteria In this case patients will be contacted by phone to provide informed consent Prospectively enrolled patients will be selected by the attending physician at the moment of the first visit if eligible and written informed consent will be obtained Patients will be enrolled if they undergo serial CT scans during the emergency evaluation as part of the standard ED care and if a sample of venous blood will be obtained at the moment of the visit Serum analysis will be performed and dosage of GFAP and UCH-L1 obtained
The collected variables will cover the following data
Demographic and anamnestic data age gender BMI past comorbidities etc
Description of the traumatic event and the time elapsed from the event to the first medical evaluation and blood sample
Clinical presentation at the moment of the first medical evaluation including vital parameters and Glasgow Coma Scale
Result of the head CT scans performed during the ED visit as well as the time at which they are performed The result will be considered as a categorical variable positive vs negative CT scan where positive will considered any detected traumatic anomaly regardless of the severity of the injury
Serum dosage of GFAP and UCH-L1 obtained at the moment of the visit
Duration of ED visit
Complications during the ED stay
Neurological deterioration defined as a decrease in GCS with respect to the arrival
Need for neurosurgical consultation
Development of seizures
Emergent neurosurgical intervention craniotomy hematoma evacuation need for invasive intra-cranial pressure monitoring etc
Need for emergent airway management due to coma
Need for ICU admission
Death for any reason
Population The study population will include all non-pregnant patients who are 18 yo and meet the pre-specified inclusion criteria We will enroll patients who present to our ED with mTBI and who undergo a venous blood sample and serial brain CT scans as part of their standard emergency care according to the present intra-hospital guidelines and the choice of the attending physician
Study duration The duration of the study will be of 18 months starting from the approval of the present protocol by the local Ethics Committee of Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome Retrospectively enrolled patients will cover the period from October 2022 up to approval of the protocol date in which the prospective enrollment will start The enrolment phase will last 12 months whilst the following 6 will be dedicated to data extraction statistical analysis and scientific reporting
Variables and procedures Retrospective data will be retrieved from our healthcare electronic system for all patients who presented to the ED with the inclusion criteria In this case patients will be contacted by phone to provide informed consent Prospectively enrolled patients will be selected by the attending physician at the moment of the first visit if eligible and written informed consent will be obtained Patients will be enrolled if they undergo serial CT scans during the emergency evaluation as part of the standard ED care and if a sample of venous blood will be obtained at the moment of the visit Serum analysis will be performed and dosage of GFAP and UCH-L1 obtained
The collected variables will cover the following data
Demographic and anamnestic data age gender BMI past comorbidities etc
Description of the traumatic event and the time elapsed from the event to the first medical evaluation and blood sample
Clinical presentation at the moment of the first medical evaluation including vital parameters and Glasgow Coma Scale
Result of the head CT scans performed during the ED visit as well as the time at which they are performed The result will be considered as a categorical variable positive vs negative CT scan where positive will considered any detected traumatic anomaly regardless of the severity of the injury
Serum dosage of GFAP and UCH-L1 obtained at the moment of the visit
Duration of ED visit
Complications during the ED stay
Neurological deterioration defined as a decrease in GCS with respect to the arrival
Need for neurosurgical consultation
Development of seizures
Emergent neurosurgical intervention craniotomy hematoma evacuation need for invasive intra-cranial pressure monitoring etc
Need for emergent airway management due to coma
Need for ICU admission
Death for any reason
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