💬In plain words
What the trial is, and whether it could suit you
Spontaneous intracerebral haemorrhage (ICH) is a life-threatening condition, still devoided of specific treatment. Peri-haematomal oedema (PHO) develops in the ensuing days after ICH onset and worsens functional outcome. Hence, PHO is a promising therapeutic target but until now there is no specific treatment for PHO. The occurrence and growth of PHO is mainly mediated by inflammation. We hypothesize that a modulation of inflammation is effective in reducing PHO growth, therefore improving the functional outcome of ICH patients. From animal studies to human post-mortem studies, our team has demonstrated a key role for erythroid-related nuclear factor 2 (Nrf2) in PHO. Indeed, this transcription factor promotes the protective effect of inflammation: Nrf2 activation enhances antioxidant defenses and increases rates of blood resorption. Therefore, Nrf2 emerges as a promising and innovative t
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Patients 18 years or older (no upper age limit)
2. Patients admitted for a first-ever or recurrent (occurred more than 1 year before) symptomatic supratentorial spontaneous ICH confirmed by brain imaging
3. Administration of study treatment no later than 48 hours after symptom onset or since last seen normal
4. Written consent obtained
5. Patient with social insurance in France
6. Patient willing to comply with all study procedures and duration
Exclusion Criteria:
1. Massive ICH for Investigational medicinal product seems futile (hematoma volume is estimated \> 60ml)
2. Severe coma (Glasgow Coma Scale \<6)
3. Pure intraventricular hemorrhage
4. ICH suspected to result from a preceding trauma, an identified intracranial vascular malformation, venous thrombosis, tumor or hemorrhagic transformation within an infarct
5. Patient planned for surgical evacuation of ICH before randomization (Evacuation, Decompressive hemicraniectomy, External ventricular drain)
6. Patient with a known indication for DRF treatment (e.g. multiple sclerosis) or any other NrF2 agonist (dimethyl fumarate; Tecfidera)
7. Patient with contraindication to DRF: patients with known hypersensitivity to DRF, or to any of the excipients of VUMERITY (patients taking dimethyl fumarate)
8. Severe lymphopenia at admission (lymphocyte counts \< 0.5 x 109/L)
9. Medical history: Suspected or confirmed of progressive multifocal leukoencephalopathy
10. Severe swallowing disorder and/or nasogastric tube required
11. Severe pre-ICH dependency (modified Rankin score of 5)
12. Life expectancy \< 1 year related to comorbidities
13. Late-stage organ (acute cardiac, renal or hepatic failure)
14. Decision already taken for palliative (end of life) care with withdrawal of active treatment
15. Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done)
16. Adults who are deprived of their liberty by judicial or administrative decision
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