Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Trial statusNot yet recruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intra-arterial and Intravenous Milrinone Therapy
Other interventionContinuous milrinone-based endovascular therapy will be administered in addition to standardized medical management. Cerebral angiography will first be performed, followed by intra-arterial infusion of milrinone 8 mg into the artery supplying the vasospastic territory over approximately 30 minutes. If vasodilation is incomplete, the infusion may be repeated once in the same territory. For diffuse vasospasm, milrinone may be administered in different vascular territories, with a maximum total intra-arterial dose of 24 mg. If severe proximal stenosis persists after intra-arterial treatment, mechanical angioplasty may be performed at the operator's discretion. After intra-arterial treatment, intravenous milrinone will be continued for 72 hours, starting at 0.5 mcg/kg/min and gradually increasing to a maximum of 1.5 mcg/kg/min when clinically needed and well tolerated. If vasospasm recurs, the treatment protocol may be repeated at the investigator's discretion.
Standardized Medical Management
Other interventionStandardized medical management will be provided after aneurysm treatment for aSAH. It will include oral or enteral nimodipine at a total daily dose of 360 mg, fluid management with 24-hour intake and output monitoring to maintain euvolemia, blood pressure augmentation when clinically indicated to support cerebral perfusion, and other guideline-recommended supportive treatments.
Treatment groups
306 Participants
are divided into 2 treatment groupsGroup A: Control Group (Standardized Medical Management Group)Active comparator 1 intervention
Group B: Experimental Group (Continuous Milrinone-Based Endovascular Therapy Plus Standardized Medical Mana )Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Neurological function prognosis
The primary outcome is poor neurological outcome within 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 3-6.
Time frame
Up to 90 days after randomizationSecondary outcomes
1
Delayed cerebral ischemia
new focal neurological deficit or decreased level of consciousness within 3 weeks after treatment, not attributable to rebleeding, seizure, infection, metabolic disturbance, or other causes, with imaging support for ischemic change (CT/MRI as applicable)
Time frame
Up to 21 days after randomization2
Vasospasm resolution rate
Proportion of participants with vasospasm resolution within 14 days after randomization, defined as a reduction in mean flow velocity of the vasospastic vessel to \<120 cm/s on transcranial Doppler, or improvement in vasospasm severity compared with baseline. CTA or DSA may be used when clinically necessary.
Time frame
Up to 14 days after randomization/at discharge3
Severity of patients' clinical condition
assessed at 14 days by WFNS grade after treatment, with change from baseline recorded
Time frame
Up to 14 days after randomization。4
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA) at baseline and 90 Days
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Time frame
at baseline and 90 days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
The First Affiliated Hospital of Zhengzhou 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, Zhejiang University, School of Medicine
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
Collaborator
Source ClinicalTrials.gov
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