Status:
UNKNOWN
Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Heart Foundation
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial\] is to determine if anakinra can ameliorate the formation of perihaematomal oedema in patients with spontaneous intracerebral haemorrhage (ICH). The main aims are: * ...
Detailed Description
Spontaneous intracerebral haemorrhage (sICH) is the deadliest stroke subtype yearly affecting over 6000 patients in the Netherlands. Treatment options are very limited. Inflammation plays a vital role...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- 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);
- Minimal intracerebral haemorrhage volume of 10 mL;
- Intervention can be started within 8 hours from symptoms onset;
- Patient's or legal representative's informed consent.
Exclusion
- Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score \< 6 at time of consent);
- Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
- Planned neurosurgical haematoma evacuation;
- Severe infection at admission, requiring antibiotic treatment;
- Known active tuberculosis or active hepatitis;
- Use of immunosuppressive or immune-modulating therapy at admission (see 15.1 Appendix A);
- Neutropenia (Absolute Neutrophil Count (ANC) \<1.5 x 109/L );
- Pre-stroke modified Rankin Scale score ≥ 3;
- Pregnancy or breast-feeding;
- Standard contraindications to MRI (see 15.2 Appendix B);
- Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration;
- Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli;
- Live vaccinations within the last 10 days prior to this ICH;
- Severe renal impairment (eGFR \<30ml/min/1.73m)
- Active malignancy
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04834388
Start Date
August 10 2022
End Date
December 1 2025
Last Update
November 18 2024
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands