CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomised controlled phase II clinical trial

Table 2 Secondary outcomes

1. The occurrence of AEs and SAEs. Blinded assessment of infections will be performed by an expert panel consisting of a microbiologist and an infectious disease specialist.
2. Blood and CSF parameters of inflammation.
3. Eculizumab concentration in the blood and CSF.
4. Daily neurological condition measured by the GCS.
5. Neurological condition measured by the NIHSS and WFNS scores on day 14 after ictus. If the patient is discharged earlier, the NIHSS and WFNS scores will be performed before discharge.
6. Cerebral infarction defined as infarction identified on brain MRI after the exclusion of procedure-related infarctions [16].
7. Cognition measured by the MoCA.
8. Quality of life measured by the EQ-5D-5L questionnaire.
9. Functional outcome measured by the mRS score. Telephone interviews will be conducted by a qualified person who is blinded for allocation.

AEs adverse events, SAEs serious adverse events, CSF cerebrospinal fluid, GCS Glasgow Coma Score, NIHSS National Institutes of Health Stroke Scale, WFNS World Federation of Neurosurgical Societies, MRI magnetic resonance imaging, MoCA Montreal Cognitive Assessment, mRS Modified Ranking Scale

ISSN: 1745-6215