Aneurysmal Subarachnoid HaemorrhageNCT05259514
CytoSorb SAH Trial
A study testing CytoSorb in people with Aneurysmal Subarachnoid Haemorrhage, run by Emanuela Keller at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Haemorrhage
- What is being tested?
- CytoSorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jan 2022to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Aneurysmal Subarachnoid Haemorrhage
- Being tested
- CytoSorb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorbDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CytoSorb |
| Standard of Care | No intervention | Only routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (2)
Reduction of IL-6 level within CSF
To evaluate whether CytoSorb effectively reduces the level of IL-6 within cerebrospinal fluid
Measured: 14 days
Removal of IL-6
To evaluate the amount of IL-6 that is removed
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start31 Jan 2022
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Why it stopped: safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuela Keller
- Sponsor type
- University, hospital or other
- Collaborators
- CytoSorbents Europe GmbH
- Responsible party
- Sponsor-investigator, Emanuela Keller, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259514
- Sponsor's protocol ID
- 2021-D0082
- Status last verified
- Aug 2022
- First submitted
- 17 Feb 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05259514
- Acronym / sponsor ID
- 2021-D0082
- Conditions
- Aneurysmal Subarachnoid Haemorrhage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: safety
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Emanuela KellerUniversity, hospital or other
- Collaborators
- CytoSorbents Europe GmbH
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- study phase 1 (feasibility/power-analysis): 5 treated with CytoSorb study phase 2: 40 (20 standard of care and 20 Cytosorb).
| Arm | Type | Receives |
|---|---|---|
| CytoSorb | Experimental | Device: CytoSorbPhase 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. |
| Standard of Care | No intervention | –Only routine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorbThe 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 |
Primary outcome
Reduction of plasma level of Interleukin-6 in patients with aSAH.
Time frame: 14 days
The primary objective is to determine, whether CytoSorb effectively reduces the plasma levels of Interleukin (IL)-6 in patients with aSAH.
2 secondary outcomes
Reduction of IL-6 level within CSF
Time frame: 14 days
Removal of IL-6
Time frame: 14 days
Results and safety
The study was stopped early (reason given: safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb in people with Aneurysmal Subarachnoid Haemorrhage, run by Emanuela Keller at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: safety). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of plasma level of Interleukin-6 in patients with aSAH. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.