Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage (RESCUE-CV)
25 de junio de 2026 actualizado por: Xinjian Yang, Beijing Tiantan Hospital
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: The RESCUE-CV Randomized 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
306
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Wenqiang Li, MD
- Número de teléfono: 13521199810
- Correo electrónico: lwqsurgeon@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100070
- Reclutamiento
- Beijing Tiantan Hospital
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Contacto:
- Wenqiang Li, MD
- Número de teléfono: 13521199810
- Correo electrónico: lwqsurgeon@163.com
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Beijing, Beijing Municipality, Porcelana, 100070
- Aún no reclutando
- Department of Neurosurgery, Beijing Tiantan Hospital
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Contacto:
- Wenqiang Li, MD
- Número de teléfono: 13521199810
- Correo electrónico: lwqsurgeon@163.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
Participants must meet all of the following criteria:
- 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.
Evidence suggestive of CVS within 14 days after onset, defined by at least one of the following:
- 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;
- TCD confirmed vasospasm, defined as mean flow velocity (MFV) >120 cm/s in the middle cerebral artery (MCA) and Lindegaard ratio >3, after excluding other causes of increased flow velocity such as anemia or fever;
- Vasospasm confirmed by DSA or CTA.
Exclusion Criteria:
- 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.
- Poor blood pressure control, defined as systolic blood pressure <100 mmHg.
- Non-aneurysmal SAH, including hemorrhage due to arteriovenous malformation, vasculitis, tumor bleeding, trauma, or other non-spontaneous causes, or cases without an identified bleeding source.
- Other severe neurological disorders with substantial pre-existing disability (mRS >3), such as progressive cognitive impairment or status epilepticus.
- Severe systemic disease, including significant cardiac, hepatic, renal, or psychiatric disorders.
- Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- Any other condition considered by the investigators to make the patient unsuitable for participation or likely to limit compliance with study procedures.
- Current participation in another interventional clinical study, inability to complete follow-up assessments, or failure to provide informed consent.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Control Group (Standardized Medical Management Group)
Participants assigned to the control group will receive standardized medical management after aneurysm treatment for aSAH, including oral or enteral nimodipine at a total daily dose of 360 mg, maintenance of euvolemia, blood pressure augmentation when clinically indicated to support cerebral perfusion, and other guideline-recommended supportive treatments.
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Standardized 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.
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Experimental: Experimental Group (Continuous Milrinone-Based Endovascular Therapy Plus Standardized Medical Mana )
Participants assigned to this arm will receive standardized medical management as described for the comparator arm plus continuous milrinone-based endovascular therapy.
Endovascular angiography will be performed, followed by intra-arterial milrinone 8 mg infused into the artery supplying the vasospastic territory over approximately 30 minutes.
The dose may be repeated if clinically needed, with a maximum total intra-arterial dose of 24 mg.
Mechanical angioplasty may be considered for persistent severe proximal stenosis.
After intra-arterial treatment, intravenous milrinone will be continued for 72 hours at 0.5 to 1.5 μg/kg/min according to clinical need and tolerability.
If vasospasm recurs, the treatment protocol may be repeated at the investigator's discretion.
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Standardized 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.
Continuous 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neurological function prognosis
Periodo de tiempo: Up to 90 days after randomization
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The primary outcome is poor neurological outcome within 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 3-6.
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Up to 90 days after randomization
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Delayed cerebral ischemia
Periodo de tiempo: Up to 21 days after randomization
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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)
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Up to 21 days after randomization
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Severity of patients' clinical condition
Periodo de tiempo: Up to 21 days after randomization。
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assessed at 3 weeks by WFNS grade after treatment, with change from baseline recorded
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Up to 21 days after randomization。
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Cognitive function assessed using the Montreal Cognitive Assessment (MoCA) at baseline and 90 Days
Periodo de tiempo: at baseline and 90 days after randomization
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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.
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at baseline and 90 days after randomization
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Health-related quality of life assessed using the EuroQol 5-Dimension questionnaire (EQ-5D) at 90 Days
Periodo de tiempo: 90 days after randomization
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Health-related quality of life will be assessed using the EuroQol 5-Dimension questionnaire (EQ-5D).
The EuroQol Visual Analog Scale (EQ VAS) score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
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90 days after randomization
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Total Hospitalization Cost
Periodo de tiempo: Up to 14 days after randomization/at discharge
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Total hospitalization cost will be calculated as the total cost incurred during the index hospitalization
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Up to 14 days after randomization/at discharge
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Length of Total Hospital Stay
Periodo de tiempo: Up to 14 days after randomization/at discharge
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Total hospital stay will be measured as the number of days from randomization to hospital discharge
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Up to 14 days after randomization/at discharge
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Length of Intensive Care Unit Stay
Periodo de tiempo: Up to 14 days after randomization/at discharge
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Intensive care unit stay will be measured as the total number of days spent in the intensive care unit during the index hospitalization
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Up to 14 days after randomization/at discharge
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Vasospasm resolution rate
Periodo de tiempo: Up to 14 days after randomization/at discharge
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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.
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Up to 14 days after randomization/at discharge
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Xinjian Yang, MD, Beijing Tiantan Hospital
- Silla de estudio: Liping Liu, MD, Beijing Tiantan Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Boulouis G, Labeyrie MA, Raymond J, Rodriguez-Regent C, Lukaszewicz AC, Bresson D, Ben Hassen W, Trystram D, Meder JF, Oppenheim C, Naggara O. Treatment of cerebral vasospasm following aneurysmal subarachnoid haemorrhage: a systematic review and meta-analysis. Eur Radiol. 2017 Aug;27(8):3333-3342. doi: 10.1007/s00330-016-4702-y. Epub 2016 Dec 21.
- Lakhal K, Hivert A, Alexandre PL, Fresco M, Robert-Edan V, Rodie-Talbere PA, Ambrosi X, Bourcier R, Rozec B, Cadiet J. Intravenous Milrinone for Cerebral Vasospasm in Subarachnoid Hemorrhage: The MILRISPASM Controlled Before-After Study. Neurocrit Care. 2021 Dec;35(3):669-679. doi: 10.1007/s12028-021-01331-z. Epub 2021 Sep 3.
- Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31.
- Jabbarli R, Pierscianek D, Rolz R, Darkwah Oppong M, Kaier K, Shah M, Taschner C, Monninghoff C, Urbach H, Beck J, Sure U, Forsting M. Endovascular treatment of cerebral vasospasm after subarachnoid hemorrhage: More is more. Neurology. 2019 Jul 30;93(5):e458-e466. doi: 10.1212/WNL.0000000000007862. Epub 2019 Jul 5.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
12 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Hemorragia
- Hemorragias intracraneales
- Condiciones Patológicas, Signos y Síntomas
- Hemorragia subaracnoidea
- Vasoespasmo Intracraneal
- Terapéutica
- Rutas de administración de drogas
- Terapia con drogas
- Infusiones, parenteral
- Infusions, Intra-Arterial
Otros números de identificación del estudio
- KY2026-149-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared because of patient privacy, ethical restrictions, and the absence of a predefined data-sharing mechanism.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .