Spontaneous subarachnoid haemorrhage.
R Loch Macdonald, Tom A Schweizer
https://pubmed.ncbi.nlm.nih.gov/27637674Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06288659
Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Led by Huashan Hospital · Updated on 2025-01-07
372
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of treatment guided by intracranial pressure (ICP) monitoring to improve outcomes for patients with aneurysmal subarachnoid hemorrhage (aSAH). Aneurysmal SAH is a severe brain hemorrhage caused by ruptured intracranial aneurysms, which leads to increased ICP and serious neurological damage. Given the high rate of elevated ICP in these patients, the study addresses a critical need for evidence on using ICP monitoring in managing aSAH. Participants will be randomly assigned to one of two groups. In the experimental group, after surgical treatment of the aneurysm, a ventricular ICP monitoring probe is implanted to guide postoperative ICP management based on measurable ICP values. The control group receives standard aSAH treatment without ICP monitoring, relying instead on clinical signs and CT imaging to assess ICP. Both groups receive similar other treatments as appropriate. During the study, participants will be followed to assess neurological outcomes, including the rate of good neurological functional prognosis at 90 days as the primary measure. Additional outcomes include prognosis at 30 and 180 days, mortality, incidence of hydrocephalus requiring shunt, delayed cerebral ischemia, and epilepsy. Safety and effectiveness will be monitored over time, with assessments conducted through clinical evaluations and imaging. The study is planned to continue until late 2026.
CONDITIONS
Brief Title
aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of aneurysmal subarachnoid hemorrhage by CT scan or lumbar puncture with ruptured intracranial aneurysm confirmed by CTA or DSA
- Decision to perform craniotomy clipping or endovascular treatment within 72 hours
- Age 18 years or older
- Onset of symptoms within 72 hours
- Hunt-Hess grade between 2 and 4
- Modified Fisher grade between 2 and 4 based on CT imaging
- Signed informed consent from patient and family members
You will not qualify if you...
- Pregnancy or lactation
- Bilateral dilated pupils upon admission
- Presence of tumors, hemorrhagic diseases, or severe chronic conditions such as COPD, multiple organ dysfunction, severe diabetes, congestive heart failure, or chronic kidney disease
- History of brain disorders or previous brain surgeries
- Hemorrhage caused by factors other than aneurysm
- Aneurysmal rupture bleeding with moyamoya disease
- Other conditions impacting prognosis
- Volunteering for ICP monitoring independently
- Participation in other ongoing clinical trials
- Any other conditions deemed inappropriate by two physicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Within 72 hours of symptom onset
Participants undergo surgery to occlude the aneurysm either by craniotomy clipping or endovascular treatment within 72 hours of symptom onset. For those in the experimental group, a ventricular ICP monitoring probe is implanted during surgery.
1 surgical procedure (in-person)
Post-operative Follow-up
Duration - Up to 180 days
After surgery, participants receive treatment guided by intraventricular ICP monitoring if applicable, or by clinical signs and CT imaging without ICP monitoring. This phase involves monitoring neurological function, ICP, and managing complications.
Multiple visits including assessments at 30, 90, and 180 days
Trial Site Locations
Total: 1 location
1
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
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Research Team
X
Xuehai Wu, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Worldwide Incidence of Aneurysmal Subarachnoid Hemorrhage According to Region, Time Period, Blood Pressure, and Smoking Prevalence in the Population: A Systematic Review and Meta-analysis.
Nima Etminan, Han-Sol Chang, Katharina Hackenberg...
https://pubmed.ncbi.nlm.nih.gov/30659573Aneurysmal Subarachnoid Hemorrhage: the Last Decade.
Sean N Neifert, Emily K Chapman, Michael L Martini...
https://pubmed.ncbi.nlm.nih.gov/33078345High-Grade Aneurysmal Subarachnoid Hemorrhage: Predictors of Functional Outcome.
Natasha Ironside, Thomas J Buell, Ching-Jen Chen...
https://pubmed.ncbi.nlm.nih.gov/30735864Outcome, Return to Work and Health-Related Costs After Aneurysmal Subarachnoid Hemorrhage.
Martin Seule, Dennis Oswald, Carl Muroi...
https://pubmed.ncbi.nlm.nih.gov/319198092023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association.
Brian L Hoh, Nerissa U Ko, Sepideh Amin-Hanjani...
https://pubmed.ncbi.nlm.nih.gov/37212182Relationship between intracranial pressure and other clinical variables in patients with aneurysmal subarachnoid hemorrhage.
Gregory G Heuer, Michelle J Smith, J Paul Elliott...
https://pubmed.ncbi.nlm.nih.gov/15352597Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study.
Chiara Robba, Francesca Graziano, Paola Rebora...
https://pubmed.ncbi.nlm.nih.gov/34146513