Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke
ACTION
Anakinra in Cerebral Haemorrhage to Target Secondary Injury Resulting From Neuroinflammation - a Phase II Clinical Trial
1 other identifier
interventional
75
1 country
1
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:
- To determine the effect of high-dose versus low-dose anakinra compared to standard medical management on perihaematomal oedema formation in the first week after ICH.
- Determine the safety profile of anakinra in these patients
- Study the effect of anakinra treatment on inflammation markers, blood-brain-barrier permeability and functional outcome. Researchers will compare treatment with anakinra for three days, in either a low or high dose, with standard medical care after ICH. Participants will:
- Be randomized to receive anakinra during three days, or receive standard medical care
- Undergo a MRI scan seven days after their ICH
- Take part in a telephone interview their functional performance three months later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 18, 2024
November 1, 2023
3.1 years
March 29, 2021
November 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Perihematomal oedema
Measured as Oedema Extension Distance (OED/EED)
7 days after ICH onset
Secondary Outcomes (4)
Adverse events of special interest (AESI) and serious adverse events (SAE)
90 days
Blood brain barriere leakage
7 days
Levels of serum inflammatory markers (IL-1β, IL-6, hsCRP)
7 days
Functional outcome
90 days
Study Arms (3)
Anakinra High dose
EXPERIMENTAL500mg i.v. loading dose, followed by continuous iv infusion with 2mg/kg/h over 3 days
Anakinra Low dose
EXPERIMENTAL100mg s.c. loading dose, followed by subcutaneous administration of 100mg twice daily for 3 days.
Standard care
NO INTERVENTIONStandard care group
Interventions
Anakinra treatment is started within 8 hours of symptom onset
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Dutch Heart Foundationcollaborator
Study Sites (1)
Radboudumc
Nijmegen, Netherlands
Related Publications (1)
Cliteur MP, van der Kolk AG, Hannink G, Hofmeijer J, Jolink W, Klijn C, Schreuder F. Anakinra in cerebral haemorrhage to target secondary injury resulting from neuroinflammation (ACTION): Study protocol of a phase II randomised clinical trial. Eur Stroke J. 2024 Mar;9(1):265-273. doi: 10.1177/23969873231200686. Epub 2023 Sep 15.
PMID: 37713268BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
F.H.B.M. Schreuder, MD PhD
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 8, 2021
Study Start
August 10, 2022
Primary Completion
September 1, 2025
Study Completion
December 1, 2025
Last Updated
November 18, 2024
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share