BLOC-ICH / Hospitals and staff

Information for participating hospitals and staff

The BLOC-ICH trial aims to recruit 80 participants.

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.

Data handling
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, Salford Royal NHS Foundation Trust and regulatory authorities for audit, inspection and monitoring purposes.

Registration
Unfortunately, new sites are unable to register for participation in this study.
Follow-up information
Participants are followed up at their 30 day and three-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.

Study protocol
You can download a summary protocol [// check document \\] for the study.

The flow chart [// check document \\] shows what will happen to each patient from approach to end to participation.

R&D information
This study is funded by the NIHR. NHS ethical approval was gained from the Health Research Authority (X) on ~~~ ~~~~~ ~~~~ (IRAS Project Number: X). The full title of this research is “Phase II trial of Interleukin-1 receptor antagonist in intracerebral haemorrhage: BLOCking the Cytokine IL-1 in ICH”.
Recruitment targets

Recruitment graphs [check document link \\]

We aim to recruit more than 80 participants by ~~~~ ~~~~.

The University of Manchester