Preventing vasospasm in patients with subarachnoid hemorrhage using cerebrospinal fluid treatment
Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Through Treatment With Intravenous Autologous Cerebrospinal Fluid - a Pilot Trial.
This study is testing if giving patients with a brain bleed a special treatment using cerebrospinal fluid can help prevent serious complications and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Trial ID | NCT04490161 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of intravenous reinstallation of cerebrospinal fluid (CSF) to prevent cerebral vasospasm in patients who have experienced aneurysmal subarachnoid hemorrhage (aSAH). The study focuses on patients aged 18 to 90 who have a cerebral saccular aneurysm and require treatment within 72 hours of symptom onset. By targeting the delayed onset of vasospasm, the trial aims to improve patient outcomes and reduce the risk of further brain injury. The methodology includes monitoring patients with external ventricular drains and assessing the efficacy of the CSF treatment in preventing complications associated with aSAH.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 who have suffered an aneurysmal subarachnoid hemorrhage and require aneurysm repair within 72 hours.
Not a fit: Patients with non-aneurysmal subarachnoid hemorrhage or those who have extensive intraventricular hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of cerebral vasospasm and improve recovery outcomes for patients with aSAH.
How similar studies have performed: While there have been studies exploring treatments for vasospasm, this specific approach using CSF reinstallation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age: \>18, \<90 * SAH HH 3 - 5 * Cerebral saccular Aneurysm * Digital subtraction angiography prior to aneurysm repair * Aneurysm repair within 72h * Modified Fisher Grade 3+4 * Presence of aneurysm needing treatment (clipping or coiling) * Treatment within 24 hours of symptom onset * External ventricular drain (clinical need) Exclusion Criteria: * Non-aneurysmal SAH * SAH HH\<3 * Extensive intraventricular haemorrhage (unable to obtain CSF without massive aspiration of clotted blood) * Contraindication for digital subtraction angiography * Aneurysm repair \>72h after rupture * Signs of radiographic vasospasm upon diagnosis * Presence of systemic or CSF infection * Contraindication for oral Nimodipin * Pregnancy
Where this trial is running
Innsbruck, Tyrol
- Medical University of Innsbruck — Innsbruck, Tyrol, Austria (Recruiting)
Study contacts
- Study coordinator: Christian F Freyschlag, MD
- Email: christian.freyschlag@i-med.ac.at
- Phone: +4350504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.