Clinical and radiological characteristics of VKA and NOAC ICH
Research type
Research Study
Full title
Clinical and radiological characteristics of non vitamin K antagonist oral anticoagulants associated ICH (NOAC-ICH) in comparison to Vitamin K Antagonist (VKA) associated ICH (VKA-ICH): multicentre international collaborative study
IRAS ID
185574
Contact name
David Wilson
Contact email
Sponsor organisation
Joint Research Office
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
It was noted that clinical and radiological characteristics of non-vitamin K antagonist oral anticoagulants associated ICH (NOAC-ICH) in comparison to Vitamin K Antagonist (VKA) associated ICH (VKA-ICH): multicentre international collaborative study:
Anticoagulants are a common drug prescribed to ‘thin the blood’ for a range of conditions and their use is increasing. Broadly speaking there are 2 types of anticoagulant; vitamin k antagonists (VKA) (of which warfarin is the most common) and direct oral anticoagulants (DOACs). Bleeding in the brain substance is the most feared complication of anticoagulation with rates of death approaching 50%. DOACs are an attractive option for both the patient and the clinician as their rate of brain bleeding is half that of warfarin. Despite this there is concern that without antidotes that brain bleeds on DOACs would be catastrophic. There is little information comparing brain bleeds and their outcomes between patients on VKA and DOACs in the medical literature; in fact the only evidence comes from a small series of 5 DOAC brain bleeds from a single centre in Japan.
This international collaboration aims to pool all DOAC and VKA brain bleeds from multiple centres from around the world so to compare the size of the bleeds and the patient outcomes. The larger number of DOAC brain bleeds we will collect will enable us to estimate whether DOACS have larger brain bleeds and worse outcomes than VKA brain bleeds with a degree of certainty that our results are truly reflective of the population.
Centres involved in a previous international collaboration would be invited to join. Patients who have had a brain bleed and are on an anticoagulant from 2012 onwards would be eligible. We would collect basic anonymised demographic information about each patient (age, gender etc) as well as information regarding the size of their brain bleed and the patients' outcome at 3 months (alive or dead). This data would be retrospective and limited to secondary use of information previously collected in the course of normal care and would not involve any patient participation. We would expect the study to last 3 months only.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0475
Date of REC Opinion
16 Oct 2015
REC opinion
Favourable Opinion