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Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage (RESCUE-CV)

10. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

306

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Department of Neurosurgery, Beijing Tiantan Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

Participants must meet all of the following criteria:

  1. Aged 18 to 80 years.
  2. SAH confirmed by cranial CT, with an intracranial aneurysm identified by CTA, MRA, or DSA and determined to be the source of bleeding.
  3. Prior treatment of the aneurysm by endovascular intervention or surgical clipping.

  4. Evidence suggestive of CVS within 14 days after onset, defined by at least one of the following:

    1. 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;
    2. 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;
    3. Vasospasm confirmed by DSA or CTA.

Exclusion Criteria:

  1. Hunt-Hess grade 5 with critical illness and inability to tolerate intervention.
  2. Contraindications to milrinone, including milrinone allergy, aortic or pulmonary valve stenosis, obstructive hypertrophic cardiomyopathy, acute coronary syndrome, or malignant arrhythmia.
  3. Perioperative procedure-related complications that may interfere with study assessment, such as significant stenosis of the parent artery.
  4. Irreversible cerebral infarction involving the entire vascular territory affected by vasospasm.
  5. Poor blood pressure control, defined as systolic blood pressure <100 mmHg.
  6. 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.
  7. Other severe neurological disorders with substantial pre-existing disability (mRS >3), such as progressive cognitive impairment or status epilepticus.
  8. Severe systemic disease, including significant cardiac, hepatic, renal, or psychiatric disorders.
  9. Pregnant or breastfeeding women, or women planning pregnancy during the study period.
  10. Any other condition considered by the investigators to make the patient unsuitable for participation or likely to limit compliance with study procedures.
  11. Current participation in another interventional clinical study, inability to complete follow-up assessments, or failure to provide informed consent.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Sonstiges: Standardized Medical Management
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.
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.
Sonstiges: Standardized Medical Management
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.
Sonstiges: Intra-arterial and Intravenous Milrinone Therapy
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Neurological function prognosis
Zeitfenster: Up to 90 days after randomization
The primary outcome is poor neurological outcome within 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 3-6.
Up to 90 days after randomization

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Delayed cerebral ischemia
Zeitfenster: Up to 21 days after randomization
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)
Up to 21 days after randomization
Vasospasm resolution rate
Zeitfenster: Up to 14 days after randomization/at discharge
Proportion of participants with vasospasm resolution within 21 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.
Up to 14 days after randomization/at discharge
Severity of patients' clinical condition
Zeitfenster: Up to 21 days after randomization。
assessed at 3 weeks by WFNS grade after treatment, with change from baseline recorded
Up to 21 days after randomization。
Cognitive function assessed using the Montreal Cognitive Assessment (MoCA) at baseline and 90 Days
Zeitfenster: at baseline and 90 days after randomization
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.
at baseline and 90 days after randomization
Health-related quality of life assessed using the EuroQol 5-Dimension questionnaire (EQ-5D) at 90 Days
Zeitfenster: 90 days after randomization
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.
90 days after randomization
Total Hospitalization Cost
Zeitfenster: Up to 14 days after randomization/at discharge
Total hospitalization cost will be calculated as the total cost incurred during the index hospitalization
Up to 14 days after randomization/at discharge
Length of Total Hospital Stay
Zeitfenster: Up to 14 days after randomization/at discharge
Total hospital stay will be measured as the number of days from randomization to hospital discharge
Up to 14 days after randomization/at discharge
Length of Intensive Care Unit Stay
Zeitfenster: Up to 14 days after randomization/at discharge
Intensive care unit stay will be measured as the total number of days spent in the intensive care unit during the index hospitalization
Up to 14 days after randomization/at discharge

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Beijing Tiantan Hospital

Mitarbeiter

The First Affiliated Hospital of Nanchang University
Chinese PLA General Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hebei General Hospital
Zhongnan Hospital
Henan Provincial People's Hospital
First Affiliated Hospital of Xinjiang Medical University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Wannan Medical College
Shaoyang Central Hospital
Binzhou Medical University
Nanfang Hospital, Southern Medical University
Ji'an Central People's Hospital
The second People's Hospital of Guiyang
The First Affiliated Hospital of Henan Medical University
Hunan University of Medicine General Hospital

Ermittler

  • Studienstuhl: Xinjian Yang, MD, Beijing Tiantan Hospital
  • Studienstuhl: Liping Liu, MD, Beijing Tiantan Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KY2026-149-02

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared because of patient privacy, ethical restrictions, and the absence of a predefined data-sharing mechanism.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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