The primary objective is to evaluate whether the concentration of six biomarkers (proteins) in SDH are related to the time of incidence of TBI. The secondary objective is to evaluate whether the fractions of the Hb-derivatives in SDH are related to…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the concentrations over time of six biomarkers
(UCHL1, ICAM5, NFH, MBP, GFAP and NGF) in subdural blood.
GFAP Glial fibrillary acidic protein
ICAM-5 Intercellular adhesion molecule 5
MBP Myelin basic protein
NFH Neurofilament heavy chain
NGF Nerve growth factor
UHCL1 Ubiquitin C-terminal hydrolase L1
Secondary outcome
The second study parameters are hemoglobin derivatives (HbO2, met-Hb, HC,
Biliverdin and Bilirubin) in subdural blood.
Hb Hemoglobin
HbO2 Oxyhemoglobin
HC Hemichrome
Background summary
Worldwide, traumatic brain injury (TBI) is the leading cause of death. For the
forensic field, determining the time of incidence of trauma is highly relevant,
since this information can lead to a suspect. This information can, in
addition, aid the reconstruction of activities and this in turn will be
beneficial for a forensic investigation and can be used in court cases. As a
result of TBI, an acute, subacute or chronic subdural hematoma (SDH) can
develop resulting in the majority of patients in surgical treatment to eleviate
symptoms. A traumatic SDH also comes with a significant mortality. Several
studies have concluded that neuroradiological determination of the time of
inci-dence of TBI using CT- or MR-scans is not reliable. Therefore, a reliable
method to determine the time of trauma is still lacking. This study will
investigate whether the time of trauma can be determined by examining various
biomarkers and Hb-derivatives in SDH.
Study objective
The primary objective is to evaluate whether the concentration of six
biomarkers (proteins) in SDH are related to the time of incidence of TBI. The
secondary objective is to evaluate whether the fractions of the Hb-derivatives
in SDH are related to the time of incidence of TBI.
Study design
This observational study will investigate markers in both acute, subacute and
chronic SDH. In the acute group, hematoma will be readily available after
craniotomy and opening of the dura. This hematoma is a firm clot and usually
discarded, but instead it will be used for research purposes. In the subacute
and chronic SDH group, only burr holes are necessary for hematoma evacuation,
and the hematoma will be acquired by transdural needle aspiration before the
dura is opened. Subsequently, as per standard operating procedure, the dura
will be opened in a cruciate fashion to remove the SDH by irrigation with
saline. All biomarkers will be measured with Surface Plas-mon Resonance Imaging
(SPRi) and calibration curves will be constructed. All hemoglobin deriv-atives
will be measured with reflectance spectroscopy, in order to establish
appropriate age mod-eling.
Study burden and risks
The patients, or legal representatives, receive an explanation of the study,
which is seen as a min-imal burden. In the acute SDH group, the blood clot
becomes readily available after craniotomy and opening of the dura. In the
subacute and chronic group, and a needle will be inserted through the dura for
a maximum depth depending on the thickness of the subdural effusion on the
pre-operative CT-scan. Therefore, the risks of obtaining the SDH are
negligible. The operation will follow the normal procedure for a SDH after the
subdural blood has been acquired. The study can only be done in this population
since this study intends to investigate a novel method to determine the time of
incidence of TBI. Mental incompetence, or cognitive impairment, is a frequent
symptom seen in TBI patients.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
* 18 years or older;
* the patients, or their legal representative, have signed an informed consent;
* have a traumatic acute, subacute or chronic subdural hematoma;
* the date of trauma must be known or when the expected trauma occurred more
than 14 days ago and the patient is not sure of the date, an approximate
estimate of the date.
Exclusion criteria
* recurrent subdural hematoma;
* previous surgery for subdural hematoma in the past 365 days;
* inability to obtain informed consent from the patient (or when the patient
has a depressed level of consciousness their legal representative), including
language barrier.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL75052.018.20 |