Information for participating hospitals and staff
The SC IL-1Ra in SAH – phase III trial aims to recruit 1,000 patients from 20 neurosurgical centres in the UK.
If your site is participating in this study, all study documentation and operating procedures are available from the principal investigator at your site. If your site is not participating in this study, patients cannot be recruited for participation.
See a list of UK hospital sites and principal investigators registered to participate in this study.
Participant data will be recorded on an electronic case report form (eCRF).
Principal investigators at participating sites are responsible for ensuring that the data included in eCRFs are accurate and complete. Only research team members who have been specifically delegated to the task are permitted to enter or change data on the eCRF.
Study data will be kept on an anonymised, password protected database, which will only be accessed by delegated members of the research team and monitoring committees from The University of Manchester, Northern Care Alliance NHS Foundation Trust and regulatory authorities for audit, inspection and monitoring purposes.
Unfortunately, new sites are unable to register for participation in this study.
Participants are followed up at their final six-month outcome assessment.
These assessments will be conducted over the telephone, unless more support is needed, in which case the assessment will take place during a routine outpatient appointment.
See the full study protocol flow chart for more information about research assessments and samples at each stage of the study.
This study is funded by the NIHR. NHS ethical approval was gained from the Health Research Authority (North West—Haydock Research Ethics Committee) on 3 November 2017 (IRAS Project Number: 214739). The full title of this research is “Does Interleukin-1 Receptor Antagonist Improve Outcome following aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III trial”.
We aim to recruit 800 aSAH participants by September 2023.
Checking the eligibility of participants
Inclusion and exclusion criteria for participating in the study.
Find out more about the consent process and who can take consent.