Status:
TERMINATED
CytoSorb SAH Trial
Lead Sponsor:
Emanuela Keller
Collaborating Sponsors:
CytoSorbents Europe GmbH
Conditions:
Aneurysmal Subarachnoid Haemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In aSAH high levels of IL-6 (a pro-inflammatory cytokine) in the cerebrospinal fluid, as well as systemically have been linked to the severity grade and the occurrence of vasospasm and delayed cerebra...
Detailed Description
Study phase 1: patients (not randomized) will be allocated to the treatment group and compared to an already existing retrospective control group. The measurements and procedures are otherwise the sam...
Eligibility Criteria
Inclusion
- Patients (age ≥ 18years) admitted to the Neurointensive Care Unit (NICU)
- Subjects with aSAH with external ventricular drainage on admission computed tomography (CT) scan due to a ruptured aneurysm confirmed by digital subtracted angiography (DSA) or computed tomography based angiography (CTA), and successfully secured aneurysm by clipping or coiling within 3 days after aneurysm rupture
- Admission WFNS grade 4-5 (high-grade aSAH)
- A physician who is not participating in the research project is called in to safeguard the interests of the person concerned before he or she is involved in the project
- Informed Consent by signature from representative
- Informed Consent (post-hoc) by signature from patient, if possible
Exclusion
- Subjects with moderate to severe vasospasm at time of admission as confirmed by CTA or DSA
- Any severe or unstable known inflammatory/immunodeficiency condition or disease (e.g. cancer, haematological, chronic infection or autoimmune disease) that might alter the natural inflammatory response
- Patients concurrently requiring immunosuppressive therapy, or who are profoundly immune suppressed
- Current infection with necessity of antibiotic treatment
- Any known coagulopathy or history of thromboembolic event leading to increased risk for thrombosis or bleeding
- Known allergies to polystyrene/divinylbenzene, polycarbonate, polypropylene, silicone and polyester
- Current pregnancy (as evaluated using a pregnancy test)
- Patients with very low platelet counts (\< 20,000/μL).
- History of heparin-induced thrombocytopenia
- Acute sickle cell crisis
- Morbid obesity with BMI ≥ 40 kg/m2
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05259514
Start Date
January 31 2022
End Date
June 16 2022
Last Update
August 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Zurich
Zurich, Switzerland, 8091