1) To unravel the pathogenesis of DCI by studying the time course of cerebral perfusion and vasospasm in patients with aneurysmal SAH with CT, and 2) to obtain a diagnostic tool for the detection of DCI on the basis of CT-perfusion (CTP) parameters…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the occurrence of DCI. This outcome will be studied with
the following study parameters: cerebral perfusion, degree of vasospasm,
ischemic changes.
Secondary outcome
not applicable
Background summary
Patients with aneurysmal subarachnoid haemorrhage (SAH) are at risk for delayed
cerebral ischaemia (DCI). This complication increases the risk for morbidity
and case fatality by 3 times and occurs in approximately one third of SAH
patients. Despite many years of research the pathogenesis of DCI is still
unclear and a diagnostic test for presence of DCI is lacking. Vasospasm has
traditionally been thought to be the main causative factor for DCI. Since only
60% op patients with vasospasm develop DCI other factors must play a role. With
novel computed tomography (CT) techniques the perfusion of brain tissue can be
visualised and measured. Data on brain perfusion and its relation with
vasospasm can give new insight in the development of DCI. Eventually diagnosis
and treatment of DCI could be improved on the basis of these new insights.
Study objective
1) To unravel the pathogenesis of DCI by studying the time course of cerebral
perfusion and vasospasm in patients with aneurysmal SAH with CT, and
2) to obtain a diagnostic tool for the detection of DCI on the basis of
CT-perfusion (CTP) parameters and degree of vasospasm.
Study design
This study is a prospective cohort study in which 250 SAH patients with and
without DCI will be compared. To study the pathogenesis, the time course of
cerebral perfusion and vasospasm will be assessed in the first 150 patients. In
this same group threshold values for the diagnosis of DCI will be established
for perfusion parameters and vasospasm. These threshold values will then be
validated in the next 100 patients.
Study burden and risks
Included patients will undergo a maximum of three additional CT scans. The risk
of cancer caused by the additional radiation is 0,5 x10-3 times higher than
normal. Due to adequate exclusion criteria there is no risk of contrast-induced
nephropathy (CIN) in this study. The risk of contrast media induced severe
acute general reactions is 0.04% per patient. Patients at risk for adverse
reactions will be excluded.
Clarifying the pathogenesis of DCI and the development of diagnostic criteria
will contribute to better diagnosis and treatment of DCI in future patients.
Heidelberglaan 100
3584CX Utrecht
NL
Heidelberglaan 100
3584CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
18 years of age or older
Aneurysmal subarachnoidal hemhorrage (SAH)
Admission within 72 hours after SAH
Exclusion criteria
Acute general reactions to or contra-indications for the admission contrast CT-scan
Impaired renal function (serum creatinin > 200umol/l)
Pregnancy
Diabetes Mellitus
Design
Recruitment
Medical products/devices used
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 | NL17943.041.07 |