Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

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

306 Participants
are divided into 2 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