Evidence map›Paper›PMID 37713268›Full record

ArticleEuropean stroke journal2024

Anakinra in cerebral haemorrhage to target secondary injury resulting from neuroinflammation (ACTION): Study protocol of a phase II randomised clinical trial.

M P Cliteur, A G van der Kolk, G Hannink, J Hofmeijer, Wmt Jolink, Cjm Klijn, Fhbm Schreuder

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in European stroke journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04834388 (Anakinra in Cerebral Haemorrhage to Target Secondary Injury Resulting From Neuroinflammation - a Phase II Clinical Trial), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04834388 phase2unknown statusnot on this map

Anakinra in Cerebral Haemorrhage to Target Secondary Injury Resulting From Neuroinflammation - a Phase II Clinical Trial

TypeinterventionalSponsorRadboud University Medical CenterRan2022 to 2025Enrolled75ConditionsIntracerebral HemorrhageArmsAnakinra
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. New targets in spontaneous intracerebral hemorrhage.Current opinion in neurology · 2025
    Review
  11. Article
  12. Review
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

M P CliteurDepartment of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-6215-5652
A G van der KolkDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
G HanninkDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.
J HofmeijerDepartment of Neurology, Rijnstate Hospital, Arnhem, The Netherlands.
Wmt JolinkDepartment of Neurology, Isala Hospital, Zwolle, The Netherlands.
Cjm KlijnDepartment of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.
Fhbm SchreuderDepartment of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-7815-0207
Radboud University Nijmegen · NLIsala · NLRijnstate Hospital · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInflammation plays a vital role in the development of secondary brain injury after spontaneous intracerebral haemorrhage (ICH). Interleukin-1 beta is an early pro-inflammatory cytokine and a potential therapeutic target.

aimTo determine the effect of treatment with recombinant human interleukin-1 receptor antagonist anakinra on perihematomal oedema (PHO) formation in patients with spontaneous ICH compared to standard medical management, and investigate whether this effect is dose-dependent.

methodsACTION is a phase-II, prospective, randomised, three-armed (1:1:1) trial with open-label treatment and blinded end-point assessment (PROBE) at three hospitals in The Netherlands. We will include 75 patients with a supratentorial spontaneous ICH admitted within 8 h after symptom onset. Participants will receive anakinra in a high dose (loading dose 500 mg intravenously, followed by infusion with 2 mg/kg/h over 72 h; OUTCOMES: Primary outcome is PHO, measured as oedema extension distance on MRI at day 7 ± 1. Secondary outcomes include the safety profile of anakinra, the effect of anakinra on serum inflammation markers, MRI measures of blood brain barrier integrity, and functional outcome at 90 ± 7 days. DISCUSSION: The ACTION trial will provide insight into whether targeting interleukin-1 beta in the early time window after ICH onset could ameliorate secondary brain injury. This may contribute to the development of new treatment options to improve clinical outcome after ICH.

Indexed as

Brain InjuriesInterleukin 1 Receptor Antagonist ProteinCerebral HemorrhageClinical Trials, Phase II as TopicEdemaHumansInterleukin-1betaNeuroinflammatory DiseasesProspective StudiesRandomized Controlled Trials as TopicInterleukin-1betaInterleukin 1 Receptor Antagonist ProteinIntracerebral haemorrhageneuroinflammationoedemaprotocolrandomised trial

Identifiers

PMID37713268
PMCPMC10916813
OpenAlexW4386757921

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.