NCT04490161 Prevention of Vasospasm in SAH Through CSF Treatment
| NCT ID | NCT04490161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Subarachnoid Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2025-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2020-01-01 with a primary completion date of 2025-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The pathophysiological mechanisms of aneurysmal subarachnoid haemorrhage (aSAH) involve early brain injury (EBI) and delayed cerebral ischemia (DCI). Several mechanisms contribute to EBI pathogenesis, including cell death, inflammatory response, oxidative stress, excitotoxicity, microcirculatory dysfunction, microthrombosis and cortical spreading depolarization. All are suggested to be linked due to common pathogenic pathways and direct interaction. Despite advances in research of diagnostics and treatment strategies, brain injury remains the major cause of death and disability in SAH patients. There is no sufficient treatment of SAH and its devastating consequences known so far. Developing and improving diagnostic methods to monitor SAH patients and to evaluate efficacy of treatment strategies are essential in SAH research. These include neuroimaging, biomarkers, and other parameters such as invasive multimodal neuromonitoring and intraoperative electrophysiological monitoring. Cerebral vasospasm (CV) - mostly responsible for DCI - can be depicted on angiograms. Altogether, tremendous efforts have been taken to conquer the occurrence and sustainability of CV. The mortality of patients suffering aSAH rises up to 50% if the patients' condition is critical (Hunt\&Hess (HH) Grade 5, WFNS Grade 5, modified Fisher Grade 4). Reports of beneficial outcome in patients with pre-existing CSF shunting have been published. The hypothesis of early CSF reapplication to the bloodstream, in order to prevent CV seems to be positively approved by the mentioned reports. Nevertheless, no data could be found on the mechanisms of action in this phenomenon. To confirm the presence of interaction of the mechanisms of EBI and evaluate the application of cerebrospinal fluid (CSF), a pilot clinical trial was planned. Due to the lack of validated animal models for aSAH it is necessary to perform the trial first-in-human. A pilot (proof of concept) trial - is done through inclusion of 10 patients with severe aSAH (≥HH4). According to clinical guidelines, these patients receive external ventricular drainages in order to drain CSF and lower intracranial pressure. An interim analysis of data will be performed after inclusion and treatment of 5 patients. Blood-/CSF-sampling for further analysis will be collected before, during and after treatment according to the study protocol.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04490161 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Subarachnoid Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04490161 currently recruiting?
Yes, NCT04490161 is actively recruiting participants. Contact the research team at christian.freyschlag@i-med.ac.at for enrollment information.
Where is the NCT04490161 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT04490161 clinical trial?
NCT04490161 is sponsored by Medical University Innsbruck. The trial plans to enroll 20 participants.