Is GenOMICC on the portfolio?
It is eligibly funded so this won't be a problem but our application has only just been submitted so we'll need to wait for confirmation.
How many patients in total are being recruited?
What is the start/end date?
GenOMICC is already recruiting. The end date for the study is 31/08/29
Are you only recruiting prospectively?
Any patient who has met our entry criteria at any time in their life is eligible for inclusion in the study. These will require individual consent and sampling, so they will count as accruals. However we are not at the moment able to provide funding to sites to search through clinical/audit databases for patients who met GenOMICC criteria and have now been discharged (retrospective recruitment). We do hope to do this in the future, subject to funding. Our reason for focusing on prospective recruitment is that we can also recruit nonsurvivors prospectively.
See the full study overview here.
Is co-enrolment allowed with other studies?
We encourage co-enrolment with other studies, including interventional studies.
How early in a ICU admission would blood samples need to be obtained?
The sample can be obtained at any time, and we don't want to put patients, relatives or research staff under excessive pressure. However, since we're studying immediately life-threatening conditions, earlier recruitment is desirable to maximise the number of very severe cases we can recruit.
Are blood samples processed at the recruiting site?
No processing of any kind is needed. Whole blood is shipped at ambient temperature. We will provide the packaging.
Are blood bottles provided for sample collection?
We are able to provide blood tubes to sites if necessary and we recognise that this is an unfunded component of the study. However most hospitals have been happy to agree to provide a small number of EDTA (full blood count) tubes from their normal clinical stock. Click here for examples of tubes to use.
Is professional consent allowed from medic independent from the research ?
This fits with our protocol as long as the initial approach is made by a member of the clinical team.
What follow up is carried out via telephone and at what time point? How long is this likely to take?
Follow-up is limited to mortality outcomes and late micro results. In our experience so far, it usually takes less than 30mins to complete the whole process.
Is there participation fee?
Sadly our funding is very tight and much of it comes from charitable donations (from clinicians, in the case of the ICS, and from the public through FEAT). For this reason we aren't able to pay for the unfunded components of the work (screening). Of course, we recognise that this will limit some sites' ability to participate. We have tried to make this as light as possible - no delegation or screening log is needed, and the CRN-supported parts of the study (consent, sampling and CRF completion) are very quick.
We are very grateful to recieve funding from the Fiona Elizabeth Agnew Trust (FEAT), the Wellcome Trust, and the UK Intensive Care Society in support of the GenOMICC study.