Stroke Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 80 years old
• People who either have never had a stroke before, or who were fully independent in daily life before this current stroke
• People who are able to receive the trial medication within 24 hours of stroke symptoms starting (for people who woke up with symptoms or whose stroke was not witnessed, the clock starts from when they were last known to be well)
• People whose stroke has been confirmed by brain imaging to affect the area supplied by the middle cerebral artery, with a stroke severity score (NIHSS) between 16 and 32, significant weakness in the arm and leg, and imaging showing a large area of damaged brain tissue meeting specific size criteria (confirm with trial site)
• People whose stroke symptoms have not improved, or have gotten worse, after clot-removal treatment, with a severity score still at or below 32
• People who have provided signed informed consent to participate

Who may not be able to join:

• People who also have bleeding in the brain or around the brain, a stroke at the back of the brain, significant narrowing of the back brain arteries, a stroke affecting both sides of the brain, or a stroke caused by artery tearing, blood vessel inflammation, or certain rare vascular conditions
• People who have bleeding within the stroke-affected area where the bleed covers 30% or more of that area and is causing dangerous pressure on the brain
• People showing signs that the brain is being dangerously compressed, such as enlarged or fixed pupils, loss of consciousness due to brain swelling, loss of brainstem reflexes, or other signs of unstable vital signs that cannot be controlled
• People for whom surgery to relieve brain pressure was already planned before entering the trial
• People with very high blood pressure (above 200/110 mmHg) or very low blood pressure (below 70/50 mmHg) that cannot be managed with medication
• People with abnormal blood sugar levels before entering the trial (either very low or very high, as measured by a blood test)
• People with significantly abnormal liver or kidney function test results before entering the trial (confirm with trial site for specific thresholds)
• People who have had a serious heart attack or severe heart failure in the past 3 months
• People for whom the trial's injection method into the skull bone cannot safely be used, for example due to a skull fracture, skull infection, blood clots around the brain, or scalp skin infection in the past 3 months
• People with bleeding disorders, including low platelet counts or conditions such as haemophilia, that the treating doctor considers a risk for the procedure
• People with severe anaemia at the time of entering the trial
• People with severe lung disease who require breathing support through a tube, tracheotomy, or ventilator
• People with serious active infections, either localised or throughout the body
• People diagnosed with severe degenerative brain diseases such as Alzheimer's disease, Parkinson's disease, severe dementia of any cause, or psychiatric conditions such as schizophrenia or depression
• People with a life expectancy of less than 3 months due to an unrelated condition such as cancer
• People with a known allergy to any component of the trial treatment or to contrast agents used in imaging
• People who are pregnant, breastfeeding, or who may become pregnant or are planning to become pregnant
• People who are unable to follow the trial procedures or attend required follow-up appointments
• People who are currently participating in another interventional clinical trial
• People who the trial investigators consider unsuitable for other reasons

Important: Always verify eligibility with the trial site directly before applying.