Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05259514 |
| Other study ID # |
2021-D0082 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 31, 2022 |
| Est. completion date |
June 16, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
