Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke

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.

Timeline

Start

2022-08-10

Primary completion

2025-09

Completion

2025-12

Publications

• Background 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.

Drugs

Indications