Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06288659

Aneurysmal Subarachnoid Hemorrhage Treatment Using Intraventricular Intracranial Pressure Monitoring A Prospective, Multicenter, Randomized Controlled Trial

Led by Huashan Hospital · Updated on 2025-01-07

372

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of intracranial pressure (ICP) monitoring to improve outcomes for patients who have experienced aneurysmal subarachnoid hemorrhage (aSAH), a serious type of brain bleeding caused by ruptured aneurysms. This condition has high rates of death and disability, and increased ICP after aSAH is common and associated with worse neurological function. The trial aims to provide high-level evidence on whether managing ICP through intraventricular monitoring can enhance patient prognosis. The study compares treatment guided by intraventricular ICP monitoring to standard care. Patients undergo craniotomy clipping or endovascular treatment within 72 hours to address the bleeding aneurysm. For those in the ICP monitoring group, postoperative management is directed by the precise ICP measurements obtained, while other treatments remain consistent with the control group. This approach allows real-time assessment and control of brain pressure. Participants are assessed through clinical evaluations, imaging, and monitoring of neurological function over time, with the primary outcome being the rate of good neurological recovery 90 days after treatment. Consent is obtained from patients and their families before enrollment. The study is prospective, multicenter, randomized, and controlled, focusing on adults with specific grades of aSAH and symptom onset within 72 hours, with safety and efficacy closely monitored throughout the trial.

CONDITIONS

Official Title

aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of aneurysmal subarachnoid hemorrhage by symptoms and CT scan or lumbar puncture, with ruptured intracranial aneurysm confirmed by CTA or DSA
  • Planned craniotomy clipping or endovascular treatment within 72 hours targeting a single procedure to treat the bleeding aneurysm
  • Age 18 years or older
  • Symptom onset within 72 hours
  • Hunt-Hess grade between 2 and 4 and modified Fisher grade between 2 and 4 on CT imaging
  • Signed informed consent from the patient and family members
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Bilateral dilated pupils at admission
  • Presence of tumors, bleeding disorders, or severe underlying conditions such as chronic obstructive pulmonary disease, multiple organ dysfunction syndrome, severe diabetes mellitus, congestive heart failure, or chronic kidney disease
  • History of brain disorders or previous brain surgeries
  • Bleeding caused by factors other than an aneurysm
  • Aneurysmal rupture bleeding with moyamoya disease
  • Other conditions affecting prognosis
  • Volunteering specifically for ICP monitoring
  • Participation in other ongoing clinical trials
  • Any other situations judged inappropriate for inclusion by two physicians

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

Loading map...

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

Similar Trials

Aneurysmal Subarachnoid Hemorrhage Multi-Omics Research Prog...

Aneurysmal Subarachnoid Hemorrhage

Actively Recruiting

1 location

Efficacy of 10 Days Intravenous Milrinone to Optimize Brain ...

Aneurysmal Subarachnoid Hemorrhage

Actively Recruiting

5 locations

COAgulation Disorders in Ischaemic and Haemorrhagic Stroke O...

Ischemic Stroke

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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/30659573

2023 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/37212182

Relationship 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/15352597

Intracranial 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