To assess the association between secondary brain injury in intracranial haemorrhage and the involved inflammatory response. We want to correlate perihematomal inflammation, serum inflammation markers, increased blood-brain-barrier leakage and…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is perihematomal oedema (measured as oedema extension distance
on MRI at day 7), which will be correlated with perihematomal uptake of
18F-DPA-714 on PET imaging at day 3 as a measure of neuroinflammation.
Secondary outcome
Secondary study parameters are the association between and the perihematomal
uptake of 18F-DPA-714 on PET imaging at day 3 and blood barrier leakage Ktrans
as measured with DCE-MRI on day 7. Furthermore the correlation with serum
inflammation markers (comparing day 1, 3 and 7 to baseline) will be assessed.
Background summary
Spontaneous intracerebral haemorrhage yearly affects over 6000 patients in the
Netherlands. It is the deadliest stroke subtype, with a 30-day case-fatality of
40%. Of patients surviving, only few gain independence. However, effective
treatment options are still lacking. This is reflected in het prognosis which
has not improved over the last 30 years. Inflammation is known to play a vital
role in the development of secondary brain injury related to intracranial
haemorrhage. The release of blood products in the brain parenchyma leads to an
activation of the immune system. This subsequently leads to destruction of the
blood brain barrier and the formation of perihematomal oedema. In vivo studies
linking serum inflammatory markers, blood brain barrier disruption and
perihematomal oedema with perihematomal inflammation are lacking.
The CHIPS study strives to assess this relation in patients with acute,
spontaneous intracerebral haemorrhage through blood sampling and MRI and PET-CT
imaging. This will provide essential insights for the development of new
treatment procedures to ameliorate secondary brain injury in intracranial
haemorrhage.
Study objective
To assess the association between secondary brain injury in intracranial
haemorrhage and the involved inflammatory response. We want to correlate
perihematomal inflammation, serum inflammation markers, increased
blood-brain-barrier leakage and perihematomal oedema.
Study design
Prospective, observational cohort study which will be executed at the Radboud
University Medical Centre (Radboudumc).
Study burden and risks
Over the course of 1 week patients will undergo; 4x blood sampling (day 0, 1, 3
and 7), 1x a PET-CT scan (day 3) and 1x a MRI scan with intravenous contrast
(day 7). The total time-invest for the individual patient will be approximately
2 hours and 20 minutes.
This risk of these procedures are negligible and the burden is considered
minimal.
The main negative consequences of performing vena puncture are local pain or
bruising. The protocol of the MRI-scan includes administration of intravenous
contrast, just as the PET-CT uses an intravenous radioactive tracer. The use of
these products can result in local symptoms as redness of the skin or a warm
feeling. Furthermore few patients experience side effects as nausea or
headache. Those are usually mild and occur in <1% of the patients. Very seldom
an allergic reaction can occur. Lastly, incidental findings on the MRI/PET-CT
need to be considered. In case of incidental clinical significant findings, the
patient*s treating physician will be notified as soon as possible to take
appropriate measures.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years;
2. Supratentorial non-traumatic ICH confirmed by CT, without a confirmed
causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF,
cerebral venous sinus thrombosis) or other known underlying lesion (e.g.
tumour, cavernoma);
3. Minimal haemorrhage volume of 10mL;
4. Inclusion within 24 hours after symptom onset;
5. Patient*s or legal representative*s informed consent.
Exclusion criteria
1. Severe infection at admission, requiring antibiotic treatment;
2. Use of immunosuppressive or immune-modulating therapy at admission;
3. Pre-stroke modified Rankin Scale score >= 3;
4. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma
Scale score < 6 at time of consent);
5. Pregnancy or breast-feeding;
6. Standard contraindications to MRI;
7. Administration of a radionuclide within 10 physical half-lives prior to
study enrolment;
8. Known prior allergic reaction to gadolinium contrast or one of the
constituents of its solution for administration;
9. Severe renal impairment (eGFR <30ml/min/1.73m);
10. Planned neurosurgical haematoma evacuation
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 | NL74920.091.20 |