In short
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for vasospasm, a serious complication that can occur after bleeding in the brain. This trial is evaluating the use of Milrinone, a medication aimed at improving blood flow by relaxing narrowed blood vessels in patients who have experienced an aneurysmal subarachnoid hemorrhage.
Clinical trial locations
Study on Milrinone Infusion for Treating Vasospasm in Patients with Aneurysmal Subarachnoid Hemorrhage
This trial is examining whether a medication called Milrinone can help improve outcomes for patients who develop vasospasm after an aneurysmal subarachnoid hemorrhage. An aneurysmal subarachnoid hemorrhage occurs when a blood vessel in the brain bursts, causing bleeding in the space around the brain. Vasospasm is a dangerous complication where these blood vessels narrow afterward, potentially reducing blood flow and causing additional brain damage.
Main inclusion criteria:
- Adults currently hospitalized for an aneurysmal subarachnoid hemorrhage
- Confirmed diagnosis of vasospasm using a cerebral angiographic CT scan
- Enrollment must occur within 6 hours of vasospasm diagnosis
- Consent provided by the patient or a relative, or through an emergency procedure
- Both male and female patients are eligible
Main exclusion criteria:
While the source does not provide detailed exclusion criteria, patients must meet the specific timing and diagnostic requirements mentioned above to participate.
Focus and goal:
The primary goal of this study is to evaluate whether Milrinone, given through an intravenous infusion, can improve neurological outcomes three months after vasospasm occurs. Researchers will measure success using a scale called the modified Rankin score, aiming for a score of 2 or less, which indicates a good recovery with minimal disability.
Throughout the study, several aspects of patient recovery will be monitored, including:
- Mortality rates in the intensive care unit, hospital, and at 3 and 6 months after the initial bleeding
- Long-term clinical outcomes measured by standardized scales
- Quality of life assessments at baseline, 3 months, and 6 months
- Imaging studies to check whether blood vessels have returned to normal and to measure any brain damage
- Length of hospital stay
- Blood pressure and metabolic indicators during treatment
Investigational drug:
Milrinone is the medication being tested in this trial. It works by inhibiting an enzyme called phosphodiesterase 3, which leads to relaxation of blood vessels and improved blood flow. In this study, Milrinone is given as an intravenous infusion at a concentration of 1 mg/ml and is compared to a placebo to determine its effectiveness. The medication is being studied specifically for its potential to reduce the narrowing of blood vessels and improve brain function after this serious complication.
Summary
This single ongoing trial represents an important effort to find better treatments for vasospasm following aneurysmal subarachnoid hemorrhage. The study is being conducted in France and focuses on the use of Milrinone, a phosphodiesterase inhibitor that may help relax narrowed blood vessels in the brain. The trial emphasizes rapid intervention, requiring enrollment within 6 hours of vasospasm diagnosis, and takes a comprehensive approach by evaluating not only immediate outcomes but also long-term recovery, quality of life, and functional independence up to 6 months after the initial bleeding. This research could provide valuable information about new treatment strategies for this serious and potentially life-threatening complication.
