NCT05259514

CytoSorb SAH Trial

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Emanuela Keller · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aneurysmal Subarachnoid Haemorrhage

Interventions

Type	Name	Description
DEVICE	CytoSorb	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.

Timeline

• Start date: 2022-01-31
• Primary completion: 2022-06-16
• Completion: 2022-06-16
• First posted: 2022-02-28
• Last updated: 2022-08-08

Locations

1 site across 1 country: Switzerland