Ongoing Clinical Trials for Ruptured Aneurysm
Two clinical trials are currently underway to investigate new treatment approaches for patients who have experienced a ruptured aneurysm leading to bleeding in the brain. These studies focus on improving recovery outcomes and reducing complications following this serious condition.
Clinical trial locations
- France
Study on Milrinone Infusion for Treating Vasospasm in Patients with Aneurysmal Subarachnoid Hemorrhage
This trial is investigating whether Milrinone, delivered through an intravenous infusion, can improve outcomes for patients who develop vasospasm after a ruptured aneurysm causes bleeding in the brain. Vasospasm is a potentially dangerous complication where blood vessels in the brain narrow, reducing blood flow and potentially causing further brain damage.
Who can participate: Adults who are hospitalized for bleeding in the brain caused by a ruptured aneurysm and who develop vasospasm confirmed by a special brain scan called a cerebral angiographic CT scan. Patients must join the study within 6 hours of the vasospasm diagnosis. Consent can be provided by the patient or a relative if the patient is unable to do so.
Who cannot participate: The trial does not specify detailed exclusion criteria in the provided information, but patients must meet the specific timing and diagnostic requirements to be eligible.
Main focus: The primary goal is to determine whether Milrinone can improve neurological recovery three months after the vasospasm occurs. Researchers will measure success using the modified Rankin score, aiming for scores of 2 or less, which indicates good functional independence. The study will also monitor mortality rates, quality of life using the EQ-5D scale, the success of blood vessel reopening seen on imaging scans, length of hospital stay, and any effects on blood pressure and metabolism.
Investigational drug: Milrinone is a medication that works by inhibiting an enzyme called phosphodiesterase 3, which helps widen blood vessels and improve blood flow to the brain. It is administered as a 1 mg/ml solution through intravenous infusion.
Study on the Effects of Dornase Alfa for Patients with Subarachnoid Hemorrhage to Improve Independence After 6 Months
This trial is testing whether dornase alfa, given daily through an IV infusion for up to 14 days, can help patients achieve better independence in their daily activities six months after experiencing bleeding in the brain from a ruptured aneurysm.
Who can participate: Adults aged 18 or older who are admitted to the hospital for bleeding around the brain caused by a ruptured aneurysm. Symptoms must have started less than 48 hours before joining the study, and the aneurysm must have been successfully treated within the last 24 hours without complications confirmed by a CT scan. The initial brain scan must show a Fisher score greater than 1, indicating a certain amount of blood present. Patients must have health insurance or social security coverage. Informed consent must be provided by the patient or a family member.
Who cannot participate: Specific exclusion criteria are not detailed in the provided information, but patients must meet all the inclusion requirements to be eligible.
Main focus: The study aims to evaluate whether dornase alfa can improve functional independence at six months, measured by the modified Rankin Scale, with scores of 0 or 1 indicating excellent outcomes. Additional assessments include checking for neurological problems, changes in consciousness levels, brain injury visible on MRI scans at 21 days, treatment needs for vasospasm, cognitive function using the MoCA-5min score, and mortality rates at 21 days. Follow-up assessments are conducted by certified professionals and radiologists who are unaware of which treatment group patients belong to.
Investigational drug: Dornase alfa is a mucolytic agent that works by breaking down DNA in fluids around the brain, which may help reduce thickness and improve clearance of these fluids. It is administered daily through intravenous infusion at a dose of 125 micrograms per kilogram of body weight.
Summary
Both ongoing clinical trials are being conducted in France and focus on improving outcomes for patients who have suffered bleeding in the brain from a ruptured aneurysm. The first trial investigates Milrinone for treating vasospasm, a narrowing of blood vessels that can occur after the initial bleeding. The second trial examines dornase alfa as a treatment given shortly after the hemorrhage to improve long-term independence. These studies reflect efforts to address both immediate complications and longer-term recovery following this serious condition. Both trials emphasize careful monitoring of neurological function, quality of life, and overall recovery using standardized assessment scales.
