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Subarachnoid Hemorrhage, AneurysmalRESCUE-CVNCT07643922

Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage

A study testing Intra-arterial and Intravenous Milrinone Therapy and Standardized Medical Management in people with Subarachnoid Hemorrhage, Aneurysmal and Cerebral Vasospasm After Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Intra-arterial and Intravenous Milrinone Therapy and Standardized Medical Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
2 sitesChina
Study dates
1 Oct 2026to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wenqiang Li, MD contact

13521199810

lwqsurgeon@163.com

China2 sites
  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

    Wenqiang Li, MD, 13521199810, lwqsurgeon@163.com

  • Department of Neurosurgery, Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100070

    Wenqiang Li, MD, 13521199810, lwqsurgeon@163.com

Other trials in China

About this study

Official title: 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.

Read more

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.

Being tested
Intra-arterial and Intravenous Milrinone Therapy, Standardized Medical Management
Keywords
aneurysmal subarachnoid hemorrhage, Cerebral vasospasm, Milrinone, Endovascular Therapy, Outcomes
Medical subject headings
Subarachnoid Hemorrhage, Vasospasm, Intracranial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-arterial and Intravenous Milrinone TherapyOther

    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.

  • Standardized Medical ManagementOther

    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.

Study groups in NCT07643922
Study groupRoleWhat they receive
Control Group (Standardized Medical Management Group)Active comparatorParticipants 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.
Receives: Other: Standardized Medical Management
Experimental Group (Continuous Milrinone-Based Endovascular Therapy Plus Standardized Medical Mana )ExperimentalParticipants 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.
Receives: Other: Intra-arterial and Intravenous Milrinone Therapy; Other: Standardized Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 90 days after randomization

Secondary outcomes (10)
  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)

    Measured: Up to 21 days after randomization

  2. 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.

    Measured: Up to 14 days after randomization/at discharge

  3. Severity of patients' clinical condition

    assessed at 14 days by WFNS grade after treatment, with change from baseline recorded

    Measured: 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.

    Measured: at baseline and 90 days after randomization

  5. Health-related quality of life assessed using the EuroQol 5-Dimension questionnaire (EQ-5D) at 90 Days

    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.

    Measured: 90 days after randomization

  6. Total Hospitalization Cost

    Total hospitalization cost will be calculated as the total cost incurred during the index hospitalization

    Measured: Up to 14 days after randomization/at discharge

  7. Length of Total Hospital Stay

    Total hospital stay will be measured as the number of days from randomization to hospital discharge

    Measured: Up to 14 days after randomization/at discharge

  8. Length of Intensive Care Unit Stay

    Intensive care unit stay will be measured as the total number of days spent in the intensive care unit during the index hospitalization

    Measured: Up to 14 days after randomization/at discharge

  9. Proportion of Participants With an Unfavorable Neurological Functional Outcome at 6 Months

    Unfavorable outcome defined as mRS score 3-6.

    Measured: 6 months after randomization

  10. Proportion of Participants With an Unfavorable Neurological Functional Outcome at 12 Months

    Unfavorable outcome defined as mRS score 3-6.

    Measured: 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
306 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07643922
Sponsor's protocol ID
KY2026-149-02
Acronym
RESCUE-CV
Status last verified
Sep 2026
First submitted
1 Jun 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because of patient privacy, ethical restrictions, and the absence of a predefined data-sharing mechanism.

Publications

  • 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.

    PubMed 34478028
  • 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.

    PubMed 28004163
  • 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.

    PubMed 18239182
  • 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.

    PubMed 31278116

Questions about this trial

What is this clinical trial studying?

A study testing Intra-arterial and Intravenous Milrinone Therapy and Standardized Medical Management in people with Subarachnoid Hemorrhage, Aneurysmal and Cerebral Vasospasm After Subarachnoid Hemorrhage, run by Beijing Tiantan Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenqiang Li, MD (13521199810, lwqsurgeon@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological function prognosis (time frame: Up to 90 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07643922, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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