Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
ConditionIntracerebral Haemorrhage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University General Hospital
About this trial
Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes without effective pharmacological treatment. Inflammation following ICH contributes to barrier disruption and peri-hematoma edema, leading to deterioration of neurological function. Preclinical evidence suggests that bone marrow hematopoietic stem and progenitor cells (HSPCs) are swiftly activated after ICH. Thereafter, these HSPCs produce an increased output of anti-inflammatory monocytes as an endogenous protective mechanism. Stimulation of β3 adrenergic receptor using selective agonists promotes the production of anti-inflammatory monocytes in bone marrow, and thereby reduces neuroinflammation, brain edema and neurological deficits. This study is to assess the safety and efficacy of a β3 adrenergic receptor agonist Mirabegron as a potential treatment option in ICH patients.
Eligibility criteria
Qualifiers
Male or female patients aged above 18 years old.
The volume of the hematoma is 5-30 ml (including the cerebral cortex; Putamen, thalamus, caudate nucleus and related deep tracts; Cerebellar hemorrhage), which determined by CT scan.
The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.
Patients with Glasgow Coma Scale (GCS) score ≥6 and < 12.
Disqualifiers
Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.
Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.
Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.
Patients who interfere with drug use due to nausea or vomiting.
Trial design
Treatments tested in this trial
- Standard treatment+mirabegron
- Standard treatment
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov