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CytoSorb SAH Trial

Primary Purpose

Aneurysmal Subarachnoid Haemorrhage

Status

Terminated

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

CytoSorb

About this trial

This is an interventional treatment trial for Aneurysmal Subarachnoid Haemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CytoSorb

Standard of Care

Arm Description

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.

Only routine treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reduction of IL-6 level within CSF

To evaluate whether CytoSorb effectively reduces the level of IL-6 within cerebrospinal fluid

Removal of IL-6

To evaluate the amount of IL-6 that is removed

Full Information

NCT ID

NCT05259514

First Posted

February 17, 2022

Last Updated

August 3, 2022

Sponsor

Emanuela Keller

Collaborators

CytoSorbents Europe GmbH

1. Study Identification

Unique Protocol Identification Number

NCT05259514

Brief Title

CytoSorb SAH Trial

Official Title

The Efficacy of CytoSorb in the Removal of IL-6 in Severe Aneurysmal Subarachnoid Hemorrhage - a Two Phase Study - a Primary Feasibility Study (Phase 1) - a Secondary Randomized, Controlled, Prospective Proof-of-concept Study (Phase 2)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

safety

Study Start Date

January 31, 2022 (Actual)

Primary Completion Date

June 16, 2022 (Actual)

Study Completion Date

June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Emanuela Keller

Collaborators

CytoSorbents Europe GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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 same as in phase 2: Patients are randomized into a treatment group and a control group. In the treatment group the study intervention consists of the installation of a central venous line, connected to a device for hemoperfusion and removal of IL-6 using a CytoSorb Adsorber. The overall objective is to evaluate efficacy, IL-6 levels will be measured daily in blood plasma as well as in cerebrospinal fluid between day 1 up to day 14 (routine procedure). Plasma and cerebrospinal fluid levels of IL-6 are evaluated using the routine samples. Furthermore, IL-6 will also be measured right after Cytosorb and the filtration to evaluate the amount of IL-6 that is actually removed by the filter (study-specific). Only post-filter blood samples are taken for study purposes. Two post-filter blood samples (10-20ml totally) are taken for study purposes: first sample one hour after installation of CytoSorb and the second sample: 24 hours after installation. Patient in the control group have standard of care treatment. The usual standard of care for the management of aneurysmal subarachnoid haemorrhage will be performed during the entire treatment period in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aneurysmal Subarachnoid Haemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CytoSorb

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Only routine treatment

Intervention Type

Device

Intervention Name(s)

CytoSorb

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Reduction of IL-6 level within CSF

Description

To evaluate whether CytoSorb effectively reduces the level of IL-6 within cerebrospinal fluid

Time Frame

14 days

Title

Removal of IL-6

Description

To evaluate the amount of IL-6 that is removed

Time Frame

14 days

Other Pre-specified Outcome Measures:

Title

Frequency of occurrence of aSAH specific complications

Description

To evaluate whether CytoSorb alters the frequency of occurrence of aSAH specific complications in (as vasospasm/DCI) in comparison to the control group as well as the outcome.

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Facility Information:

Facility Name

University Hospital Zurich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

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CytoSorb SAH Trial

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