NCT05259514

CytoSorb SAH Trial

Terminated NA Last updated 8 August 2022

What this trial tests

NA trial testing CytoSorb in Aneurysmal Subarachnoid Haemorrhage in 2 participants. Terminated before completion.

Timeline

31 January 2022

Primary endpoint
16 June 2022

16 June 2022

Quick facts

Lead sponsor	Emanuela Keller
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	31 January 2022
Primary completion	16 June 2022
Estimated completion	16 June 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• CytoSorb

Conditions studied

• Aneurysmal Subarachnoid Haemorrhage — all drugs for Aneurysmal Subarachnoid Haemorrhage →

Sponsor

Emanuela Keller

Who can join

18 and older, any sex, with Aneurysmal Subarachnoid Haemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Contemporary management of aneurysmal subarachnoid haemorrhage. An update for the intensivist.
   Robba C, Busl KM, Claassen J, Diringer MN, et al · · 2024 · cited 66× · PMID 38598130 · DOI 10.1007/s00134-024-07387-7
2. Systemic Inflammation after Aneurysmal Subarachnoid Hemorrhage.
   Chai CZ, Ho UC, Kuo LT. · · 2023 · cited 38× · PMID 37446118 · DOI 10.3390/ijms241310943