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Cerebral Haemorrhage associated Inflammation: a PET/MRI Study

Cerebral Haemorrhage associated Inflammation: a PET/MRI Study - CHIPS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49603
Enrollment
10
Registered
2021-01-04
Start date
2021-04-18
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral hemorrhage hemorrhagic stroke

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)