CytoSorb SAH Trial

NCT05259514 | Terminated

• 1 other identifier: 2021-D0082
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 cerebral ischemia caused by vasospasm as well as worse outcome independent of severity grade at time of admission and age. Increased levels of IL-6 increase the probability of unfavourable outcome, as well as the occurrence of delayed ischemic neurological deficit. CytoSorb is an available, and certified medical device intended for use in conditions where elevated levels of cytokines such as IL-6 exist. Its clinical effect lies in the reduction of levels of pro-inflammatory mediators and thereby improving organ function as well as improving hemodynamic stability within hours of treatment initiation. Currently it is primarily used for the treatment of patients with confirmed or imminent respiratory failure who have either an acute lung injury, or acute respiratory distress syndrome, or a severe disease incl. respiratory failure, septic shock, and or multiple organ dysfunction/failure. Until now, effective IL-6 removal in patients suffering from aSAH has not been possible in human and thus has not yet been evaluated. The purpose of this study is to see whether removal of IL-6 in patients with aSAH using CytoSorb is possible, and whether this alters the clinical course. The overall goal of this study is to investigate whether a treatment with CytoSorb removes Interleukin 6 in patients with aSAH, and whether the treatment with CytoSorb alters the clinical course.

Conditions

Aneurysmal Subarachnoid Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Reduction of plasma level of Interleukin-6 in patients with aSAH.

  The primary objective is to determine, whether CytoSorb effectively reduces the plasma levels of Interleukin (IL)-6 in patients with aSAH.

  14 days

Secondary Outcomes (2)

• Reduction of IL-6 level within CSF

  14 days

• Removal of IL-6

  14 days

Other Outcomes (1)

• Frequency of occurrence of aSAH specific complications

  14 days

Study Arms (2)

CytoSorb

EXPERIMENTAL

Phase 2: 40 (20 each in treatment and control group). The Study Product is CytoSorb. Patients included will receive a CytoSorb filter. The device has a CE-mark and is used in accordance with its CE-Certification. Patients are installed as early as possible after exclusion of the bleeding source and are treated with the CytoSorb Adsorber for 48 hours. Blood flow will be set at least 200 ml/min.

Device: CytoSorb

Standard of Care

NO INTERVENTION

Only routine treatment

Interventions

CytoSorb DEVICE

The Study Product is CytoSorb. Patients included will receive a CytoSorb filter. The device has a CE-mark and is used in accordance with its CE-Certification. Patients are installed as early as possible after exclusion of the bleeding source and are treated with the CytoSorb Adsorber for 48 hours. Blood flow will be set at least 200 ml/min.

CytoSorb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emanuela Keller: lead
• CytoSorbents Europe GmbH: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: study phase 1 (feasibility/power-analysis): 5 treated with CytoSorb study phase 2: 40 (20 standard of care and 20 Cytosorb).

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: January 31, 2022
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

CH (1)