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Tests treatment safety and results for Intracerebral Haemorrhage
Official title Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage
ClinicalTrials.gov ID: NCT05369351
What this study is testing
What is Standard treatment+mirabegron?
Standard treatment+mirabegron is an investigational medicine, being studied as a potential treatment for intracerebral haemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
- Before the onset of the disease, function was independent and mRS score\<1.
You likely can't join if
- Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.
- Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain...
- Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically...
- Patients who interfere with drug use due to nausea or vomiting.
- Combined with the following conditions that preclude participation in the study due to other systemic diseases: Severe hepatic or renal impairment...
See the full eligibility criteria
- 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.
- Before the onset of the disease, function was independent and mRS score\<1.
- Able and willing to sign written informed consent and comply with the requirements of the research protocol.
- 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.
- Combined with the following conditions that preclude participation in the study due to other systemic diseases: Severe hepatic or renal impairment, atrial fibrillation or tachycardia, pulmonary infection, severe urinary...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.