We have received a favourable opinion and HRA/HCRW approval for the substantial protocol amendment we submitted to incoporate Secondary ITP to the UK Adult ITP Registry.
With this latest substantial protocol amendment (version 4.0), the eligibility criteria has been expanded to include secondary ITP, i.e. cases triggered by other conditions. Work is still ongoing in the background to incorporate the full secondary ITP dataset as a third arm in the registry REDCap database. Therefore, in the first instance, sites should on only consent and capture data on participants where ITP was seen following a vaccine (e.g. after a COVID-19 vaccine). This data is captured in the new ‘Vaccination History’ form.
There are no changes in the processes to recruit participants with primary ITP and pregnancy ITP.
Once all the testing has been completed, the Secondary ITP arm will be added to the REDCap database, where sites will be able to consent and capture data on secondary ITP cases (e.g. Evans syndrome, Lupus, HIV etc). We will keep all sites updated of any further developments and when this is live.
If you have any questions, please do not hesitate to contact us.
The amendment pack with all the related study documents can be downloaded here: Substantial amendment 7 document pack [5,425KB]
The ITP Registry team is now accepting blood samples from all sites again.
If there are any patients who have previously consented to donating bloods for the registry study but you have not taken any bloods due to the hold, please go ahead and obtain the bloods from the relevant patients when they next attend your hospitals/clinics.
Full details relating to the blood sample collection can be found in page 10 of the protocol.
Please ensure that all patient identifiable information have been removed from the EDTA tubes and replaced with the Registry Identification Code (RIC) and ITP reference number, which can be found in your participant logs.
If you have any questions relating to the blood sample collection aspect of the protocol, please do not hesitate to contact us.
The REDCap database for the UK Adult ITP Registry has been updated to include COVID-19 infections in ITP patients, and can be found under the comorbidities section of the REDCap database, as with other infections. This is a simple dataset capturing information about the severity of ITP. We will also capture vaccination.
Whilst updating the database, we have also added Fostamatinib and Avatrombopag as treatment options. A minor amendment has been processed and the data capture forms have been updated accordingly.
Do let us know if you have any questions around this.
We have recently updated our protocol and related study documents to enable sites to consent potential patients remotely, i.e. not requiring to see the patient in person in hospital/clinic. The amendment pack has been sent to all sites and can be implemented with immediate effect.
The latest study documents can be found on the following link.
Due to the COVID-19 outbreak in the UK, there is a possibility that sites may not be able to recruit patients into the registry. Patient safety is paramount and we understand if hospitals decide to halt recruitment for the UKITPR in line with their local policies and use clinical staff aligned to research projects to support NHS resource demands. You do not have to inform us that this is the case; please proceed as instructed by your local research management teams. In addition to this, we are requesting for sites to not collect or send DNA samples for patients in the ITP registry until further notice. We will keep you posted with further developments as needed. Thank you for your hard work. Please do not hesitate to contact us if you have any questions or concerns.
Moving into 2020, and after a very busy 2019, we are delighted to inform you that 2019 was the highest recruiting year on record for the UK Adult ITP registry with a total of 544 adults recruited. In addition to this, 19 patients have been recruited to the pregnancy registry.
Ahead of the next newsletter, we wanted to share this news and say a big thank you to all the teams involved for the hard work. We look forward to further development of the registry in year ahead.Wishing you all a very happy and productive 2020.
You may already be aware that participant entry into the NIHR Central Portfolio Management System (CPMS) for trials is changing. As of 1st June 2019, sites are expected to upload their own recruitment figures on to a Local Portfolio Management System (LPMS). This can either be EDGE, ReDA or an alternative system, depending on whether your site is in England, Northern Ireland, Scotland or Wales.This will have an impact on how recruitment to the registry is recorded. The new process will be as follows:
Sites consent the patient locally.
Sites upload their recruitment onto their LPMS. This then feeds through onto the CPMS.
Sites send their signed consent forms and updated participants logs to the UK ITP Registry inbox.
At the beginning of each month, the UK ITP Registry team will review the recruitment figures uploaded onto CPMS from the previous month and correlate with the participants logs received from each site to ensure there are no discrepancies.
Any discrepancies identified will be raised with the sites/NIHR as relevant.
Once resolved, UK ITP Registry team will confirm recruitment for that month.
If you haven’t sent through the consent forms and participant logs for all patients consented before 31st may 2019, please can you send these through as soon as possible, so that we can ensure that the recruitment figures on CPMS are correct up to the changeover.If you have any queries relating to transition, please do not hesitate to contact us.