Article ; Online: Anakinra in cerebral haemorrhage to target secondary injury resulting from neuroinflammation (ACTION): Study protocol of a phase II randomised clinical trial.
2023 Volume 9, Issue 1, Page(s) 265–273
Abstract: Background: Inflammation 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.: Aim: To ... ...
| Abstract | Background: Inflammation 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. Aim: To 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. Methods: ACTION 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. |
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| MeSH term(s) | Humans ; Interleukin-1beta ; Interleukin 1 Receptor Antagonist Protein/adverse effects ; Neuroinflammatory Diseases ; Prospective Studies ; Cerebral Hemorrhage/drug therapy ; Edema ; Brain Injuries ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase II as Topic |
| Chemical Substances | Interleukin-1beta ; Interleukin 1 Receptor Antagonist Protein |
| Language | English |
| Publishing date | 2023-09-15 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article |
| ZDB-ID | 2851287-X |
| ISSN | 2396-9881 ; 2396-9873 |
| ISSN (online) | 2396-9881 |
| ISSN | 2396-9873 |
| DOI | 10.1177/23969873231200686 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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