Treatment of cerebral vasospasm following aneurysmal subarachnoid haemorrhage: a systematic review and meta-analysis.
Grégoire Boulouis, Marc Antoine Labeyrie, Jean Raymond...
https://pubmed.ncbi.nlm.nih.gov/28004163/Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2026-06-29
306
Participants Needed
2
Research Sites
52 weeks
Total Duration
Cerebral vasospasm is a serious complication that can occur after aneurysmal subarachnoid hemorrhage and often leads to delayed cerebral ischemia and poor neurological outcomes. Effective treatments for this condition remain limited despite standard medical care. This trial is a multicenter, prospective, randomized controlled study aiming to evaluate whether early continuous milrinone-based endovascular therapy can improve outcomes in patients experiencing cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Participants will be randomly assigned to one of two groups. The control group will receive standardized medical management including oral or enteral nimodipine, fluid and blood pressure management, and other supportive treatments. The experimental group will receive the same standardized care plus continuous milrinone-based endovascular therapy. This includes intra-arterial milrinone infusion into the affected artery, possible mechanical angioplasty if needed, followed by a 72-hour intravenous milrinone infusion. The dosing may be repeated if vasospasm recurs. Participants will be monitored for neurological function prognosis up to 90 days after randomization. Additional assessments include delayed cerebral ischemia, vasospasm resolution, clinical condition severity, cognitive function measured by the Montreal Cognitive Assessment, quality of life via the EuroQol 5-Dimension questionnaire, hospitalization costs, and length of hospital and ICU stays. The studys total duration extends up to the end date in 2029, with ongoing evaluations and follow-ups during this period.
CONDITIONS
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
W
Wenqiang Li, MD
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Beijing Tiantan Hospital
Lead Sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 or more visits to evaluate eligibility
Duration - Up to 14 days after randomization
Participants receive either standardized medical management alone or milrinone-based endovascular therapy plus standard care. The milrinone treatment involves intra-arterial infusion during endovascular angiography, possible mechanical angioplasty, and a 72-hour intravenous infusion.
Regular monitoring visits during hospitalization
Duration - Up to 90 days after randomization
Participants are followed for neurological function, cognitive assessments, quality of life, and other health outcomes up to 90 days after randomization.
Periodic follow-up visits or assessments
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor