Phase 1 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 79 years old
• People who have signs of an acute ischemic (non-bleeding) stroke with a stroke severity score of 6 or higher on a standard medical scale
• People whose brain CT scan shows an ASPECTS score of 6, which is a measure of how much brain tissue appears healthy on the scan
• People whose stroke symptoms began less than 16 hours before the start of a clot-removal procedure (called mechanical thrombectomy)
• People whose CT scan of the blood vessels shows a blockage in a specific major artery on one side of the brain (the MCA M1 or dominant proximal M2 segment)
• People whose CT perfusion scan (a special scan measuring blood flow) shows a core area of damage less than 70ml, a surrounding at-risk brain tissue area of at least 15ml, and a ratio of at-risk tissue to damaged tissue of 1.8 or greater
• People who were functioning well before the stroke, with a disability score of 2 or lower on a standard scale
• People for whom the medical team has already planned to use general anaesthesia (full unconsciousness with a breathing tube) for the clot-removal procedure
• People, or their authorised representative, who are able to provide consent to participate

Who may not be able to join:

• People with blood pressure that is too low (below 100/60) or dangerously high (above 185 systolic or 110 diastolic) and unable to be controlled with IV medication
• People who cannot safely have a brain MRI scan, for example due to having an implanted pacemaker
• People who received a clot-dissolving medication (tPA) more than 4.5 hours after their stroke symptoms began
• People with serious blood clotting problems, such as very low platelet counts, high clotting time results, or use of certain blood thinners with significantly reduced kidney function
• People considered vulnerable, including those who are mentally ill or have reduced decision-making ability, prisoners, people admitted for long-term chronic illness, people who are terminally ill, pregnant women, and children
• People whose brain CT scan shows any bleeding or a mass (such as a tumour) in the brain
• People who have had a serious head injury within the past 90 days
• People with a pre-existing severe brain or psychiatric condition
• People who had a seizure at the time their stroke started, making it impossible to properly assess stroke severity
• People with blood sugar levels that are very low (below 50 mg/dL) or very high (above 400 mg/dL)
• People with a low haemoglobin level (below 7 mmol/L), indicating significant anaemia
• People with severely reduced kidney function (eGFR below 30 ml/min)
• People with a known allergy to contrast dye used in scans
• People whose stroke is thought to have been caused by an infected blood clot (septic embolus)
• People with significant narrowing or complete blockage of the carotid arteries (the main arteries in the neck or base of the brain) that restricts blood flow

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