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New treatment option for Subarachnoid Hemorrhage, Aneurysmal
Official title Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
ClinicalTrials.gov ID: NCT07643922
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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:
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- 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 treatment clinical study, inability to complete follow-up assessments, or failure to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.