Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581757
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Evaluation of the Predictive Value of Serum Glial Fibrillary Acidic Protein and Ubiquitin Carboxy-terminal Hydrolase L1 for Subarachnoid Haemorrhage
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Predictive Value of Serum Glial Fibrillary Acidic Protein and Ubiquitin Carboxy-terminal Hydrolase L1 for Subarachnoid Haemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To verify the analytical performance of GFAP and UCH-L1 biomarkers marketed by Abbott Diagnostics and to assess diagnostic accuracy of these biomarkers in predicting subarachnoid haemorrhage
Detailed Description:
Subarachnoid haemorrhage SAH refers to blood entering the subarachnoid space and may be due to aneurysmal or non-aneurysmal causes Patients with SAH characteristically present with a sudden onset thunderclap headache Patel et al 2021 This is an acute medical emergency and is the third most common type of stroke with approximately 500000 cases annually across the world Claassen and Park 2022 Morbidity has decreased over the past few decades however there is still an approximate 35 occurrence of death within three months of a SAH Andersen et al 2019 Early diagnosis is important to enable timely treatment and thereby improve prognosis Current NICE guideline NG228 state the diagnosis of SAH is to be made from a non-contrast CT scan showing the presence of blood in the subarachnoid space A negative CT done within 6 hours of symptom onset is considered not indicative of a SAH If however the CT is negative and is performed more than 6 hours after onset of symptoms then a LP is advised to look for the presence of xanthochromia in the CSF NICE 2022
Xanthochromia refers to the yellowing of the cerebrospinal fluid CSF due to accumulation of bilirubin from the breakdown of red blood cells in the subarachnoid space Its presence in the appropriate clinical context confirms a diagnosis of SAH In our population approximately 10 of CSF xanthochromia tests confirm SAH meaning 90 of LPs may not have been necessary This test is reliable only if performed at least 12 hours after the onset of symptoms The xanthochromia test is considered a manual test and requires trained and competent staff There are multiple pre-analytical requirements in order to produce a reliable result For example the sample must be protected from light during transport and not transported by the air tube Exposure to light can cause the bilirubin to breakdown which can then lead to a false negative result Cruickshank et al 2008 Samples transported in the pneumatic tube system may give false results due to the lysis of red cells
Traumatic tap in which the needle causes blood to enter the subarachnoid space and which will then be present in the CSF sample can also cause interference as discolouration of the sample may mask xanthochromia The least bloodstained CSF sample must therefore be used for analysis Finally an LP is an invasive procedure and is therefore an unpleasant experience for the patient Long et al 2017
In summary a test for SAH that is subject to fewer pre-analytical and analytical interferences would be superior to the current CSF xanthochromia test Whilst it is not expected that a serum test could replace the need for CSF xanthochromia completely a test that could identify which patients are likely to have negative LP could reduce the number of unnecessary LPs
There are two candidate biomarkers - Ubiquitin C-terminal hydroxylase-L1 UCH-L1 and Glial Fibrillary Acidic Protein GFAP - which have been found to increase in blood following brain damage and in traumatic brain injuries including SAH However current guidelines NICE 2022 for SAH state that brain biomarkers are not currently recommended by guidelines as part of the SAH diagnosis pathway
Xanthochromia refers to the yellowing of the cerebrospinal fluid CSF due to accumulation of bilirubin from the breakdown of red blood cells in the subarachnoid space Its presence in the appropriate clinical context confirms a diagnosis of SAH In our population approximately 10 of CSF xanthochromia tests confirm SAH meaning 90 of LPs may not have been necessary This test is reliable only if performed at least 12 hours after the onset of symptoms The xanthochromia test is considered a manual test and requires trained and competent staff There are multiple pre-analytical requirements in order to produce a reliable result For example the sample must be protected from light during transport and not transported by the air tube Exposure to light can cause the bilirubin to breakdown which can then lead to a false negative result Cruickshank et al 2008 Samples transported in the pneumatic tube system may give false results due to the lysis of red cells
Traumatic tap in which the needle causes blood to enter the subarachnoid space and which will then be present in the CSF sample can also cause interference as discolouration of the sample may mask xanthochromia The least bloodstained CSF sample must therefore be used for analysis Finally an LP is an invasive procedure and is therefore an unpleasant experience for the patient Long et al 2017
In summary a test for SAH that is subject to fewer pre-analytical and analytical interferences would be superior to the current CSF xanthochromia test Whilst it is not expected that a serum test could replace the need for CSF xanthochromia completely a test that could identify which patients are likely to have negative LP could reduce the number of unnecessary LPs
There are two candidate biomarkers - Ubiquitin C-terminal hydroxylase-L1 UCH-L1 and Glial Fibrillary Acidic Protein GFAP - which have been found to increase in blood following brain damage and in traumatic brain injuries including SAH However current guidelines NICE 2022 for SAH state that brain biomarkers are not currently recommended by guidelines as part of the SAH diagnosis pathway
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None