About this trial
Cerebral vasospasm is a common and serious complication after aneurysmal subarachnoid hemorrhage and is an important cause of delayed cerebral ischemia and poor neurological outcomes. Although standardized medical management is widely used, effective treatment options for cerebral vasospasm remain limited.
Endovascular treatment, including intra-arterial drug infusion and mechanical angioplasty, may relieve vasospasm and improve cerebral perfusion after aneurysmal subarachnoid hemorrhage. However, most available evidence comes from retrospective or observational studies, and high-quality randomized evidence remains insufficient. Milrinone is a phosphodiesterase inhibitor with multiple potentially beneficial effects, including vasodilation, positive inotropic activity, anti-inflammatory properties, and endothelial protection. These effects may make milrinone a promising therapeutic agent for relieving cerebral vasospasm, reducing delayed cerebral ischemia, and ultimately improving clinical outcomes after aneurysmal subarachnoid hemorrhage.
This study is a multicenter, prospective, randomized controlled clinical trial designed to evaluate whether early continuous milrinone-based endovascular therapy improves outcomes in patients with cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Eligible participants will be randomly assigned to receive either standardized medical management alone or milrinone-based endovascular therapy plus standardized medical management. In the intervention group, patients will receive intra-arterial milrinone during endovascular treatment, with mechanical angioplasty when clinically indicated, followed by continuous intravenous milrinone infusion for 72 hours after intra-arterial administration.
The study will evaluate whether this continuous treatment strategy reduces poor neurological outcomes at 3 months after randomization. It will also assess the effects of treatment on delayed cerebral ischemia, vasospasm resolution, cognitive function, quality of life and so on. The results of this trial may provide high-quality evidence for early continuous milrinone-based endovascular therapy as a treatment strategy for cerebral vasospasm after aneurysmal subarachnoid hemorrhage.
Eligibility criteria
Qualifiers
Aged 18 to 80 years.
SAH confirmed by cranial CT, with an intracranial aneurysm identified by CTA, MRA, or DSA and determined to be the source of bleeding.
Prior treatment of the aneurysm by endovascular intervention or surgical clipping.
Clinical deterioration, including a decrease in GCS score of >2 points and/or a new focal neurological deficit not attributable to another known neurological cause;
Disqualifiers
Hunt-Hess grade 5 with critical illness and inability to tolerate intervention.
Contraindications to milrinone, including milrinone allergy, aortic or pulmonary valve stenosis, obstructive hypertrophic cardiomyopathy, acute coronary syndrome, or malignant arrhythmia.
Perioperative procedure-related complications that may interfere with study assessment, such as significant stenosis of the parent artery.
Irreversible cerebral infarction involving the entire vascular territory affected by vasospasm.
Trial design
Treatments tested in this trial
- Intra-arterial and Intravenous Milrinone Therapy
- Standardized Medical Management
Treatment groups
Sponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
The First Affiliated Hospital of Henan Medical University
Collaborator
Hebei General Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
Binzhou Medical University
Collaborator
Hunan University of Medicine General Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
First Affiliated Hospital of Wannan Medical College
Collaborator
Zhongnan Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Chinese PLA General Hospital
Collaborator
Shaoyang Central Hospital
Collaborator
Ji an central people's Hospital
Collaborator
The second People's Hospital of Guiyang, China
Collaborator