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

2026년 6월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

306

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100070
        • Department of Neurosurgery, Beijing Tiantan Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
다른: 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.
실험적: 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.
다른: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Neurological function prognosis
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Delayed cerebral ischemia
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Tiantan Hospital

협력자

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

수사관

  • 연구 의자: Xinjian Yang, MD, Beijing Tiantan Hospital
  • 연구 의자: Liping Liu, MD, Beijing Tiantan Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 6월 1일

QC 기준을 충족하는 최초 제출

2026년 6월 10일

처음 게시됨 (실제)

2026년 6월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 10일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KY2026-149-02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Standardized Medical Management에 대한 임상 시험

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위치

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