UNIVERSITY COLLEGE LONDON (UCL): The Clinical Relevance of Microbleeds in Stroke (CROMIS-2) study is an observational inception cohort study of patients throughout the UK (80 hospitals) started on best practice or

Data-sharing agreement from NHS Digital registers of approved data releases, 2014–2019. Evidence status: source reported.

Organisation: University College London (UCL)
Source reference: DARS-NIC-18646-P0R3M-v0.9
Jurisdiction: England
Licence: Open Government Licence v3.0, subject to NHS England terms and exclusions

Register reference: DARS-NIC-18646-P0R3M-v0.9
Agreement period: not published to no end date published
For commercial purposes (as marked in the register): Not stated
Release files listed by NHS England: 28

Data approved

Hospital Episode Statistics Accident and Emergency
Hospital Episode Statistics Admitted Patient Care
Hospital Episode Statistics Critical Care
Hospital Episode Statistics Outpatients

Objective, as published

The Clinical Relevance of Microbleeds in Stroke (CROMIS-2) study is an observational inception cohort study of patients throughout the UK (80 hospitals) started on best practice oral anticoagulant (without prior use) for presumed cardioembolic ischaemic stroke due to non-valvular AF with follow up for the occurrence of ICH, ischaemic stroke and cognitive function for two years. Over the last decade, increasing use of oral anticoagulants to prevent cardioembolic ischaemic stroke due to atrial fibrillation (AF) in an ageing population has led to a five-fold increase in the incidence of anticoagulant-related intracranial haemorrhage (ICH) - a rare but unpredictable and catastrophic complication. Cerebral microbleeds (CMBs) on magnetic resonance imaging (MRI) may predict ICH risk, as may genetic polymorphisms influencing brain small-vessel integrity or anticoagulation stability. The CROMIS-2 study aims to establish the value of CMBs and genetic factors in predicting symptomatic ICH following best practice oral anticoagulation to prevent recurrent ischaemic stroke due to AF. The data provided by NHS Digital about patients recruited to the CROMIS-2 study will inform UCL when an outcome event occurs during their 24 month follow up period. This supports the objectives of the study and will allow reporting on the whole study population, and helps ensure families are not approached after a relative’s death. The study has also recruited patients admitted to participating centres with i…

Expected benefits, as published

Both CROMIS-2 non vitamin k oral anticoagulant (NOAC) ICH and non NOAC ICH should expect to add a great deal to the understanding, prevention and management of ICH. Published papers: 1) This paper outlined how NOAC intracerebral haemorrhage volumes were smaller and clinical outcomes better when compared with warfarin intracerebral haemorrhage in the CROMIS-2 data set. This may lead clinicians to have more confidence in prescribing non vitamin K oral anticoagulants as there has been previous cncern that ICH on these medications would be large and devastating. 2) This paper outlines current vitamin K reversal stratergies in ICH and their correlation with clinical outcome. We were able to show the combination of fresh frozen plasma and prothrombin complex concentrate might be associated with…

Source: https://webarchive.nationalarchives.gov.uk/ukgwa/2019/http://content.digital.nhs.uk/media/24614/Release-Register-March---May-2017/xls/Release_Register__March_-_May_20171.xlsx. Captured 2026-10-30.

Limitations: Agreement as recorded in an NHS Digital register of approved data releases (2014–2019), retrieved from the UK Government Web Archive. That register lists releases made in its period and the agreement's purpose statement as it then stood; it gives no agreement dates, and the agreement may have changed since. Imported only where a paper quotes a reference no current register holds.