Status
Ongoing
Title
Antibiotic treatment and major bleeding amongst people using blood-thinning medications (anticoagulants)
What is the aim of the study and why is it important?
The aim of this study is to find out which antibiotics might lead to bleeding amongst people who use blood-thinning medications, known as anticoagulants.
Why is this important?
The main anticoagulants used in the UK are warfarin and a group of drugs known as Direct Oral Anticoagulants, or DOACs. Their main use is to prevent blood clots and stroke in people with an irregular heart rhythm. Bleeding is the most serious complication of using anticoagulant medication. Some antibiotics can interact with anticoagulants and increase the chance of a major bleed. However, we don’t know which antibiotics safe. It is important to know which antibiotics may lead to bleeding to help healthcare professionals avoid harmful antibiotics but not unnecessarily avoid those that are safe.
How is the research being done?
This project will use anonymised healthcare data from a secure and well-established database known as QResearch. QResearch holds anonymised data from general practices across England that can be linked to hospital admission and death certificate data. We will use these data to select a group of anticoagulant medication users. We will select those who were prescribed an antibiotic at the same time as they used anticoagulant medication to find out which of those led to a major bleed. We will compare the 10 most commonly prescribed antibiotics in the UK to find out which are associated with an increased risk of bleeding and answer the question of which antibiotics are safe to prescribe to anticoagulant medication users.
Chief Investigator
Dr Haroon Ahmed - Cardiff University
Lead Applicant Organisation Name
Sponsor
University of Oxford
Location of research
Oxford
Date on which research approved
14-Jul-2022
Project reference ID
OX164
Generic ethics approval reference
18/EM/0400
Are all data accessed are in anonymised form?
Yes
Brief summary of the dataset to be released (including any sensitive data)
EMIS: General Practice data will be required to include people who use blood thinning medication and describe their characteristics such as sex, age, deprivation index, alcohol status, smoking status, and the absence or presence of a range of risk factors and long-term conditions such as cancer, heart disease, kidney disease, high blood pressure, stroke, and liver disease. We will also describe use of certain medications like anti-inflammatory drugs.
HES: HES data is necessary to find out who had one of our bleeding outcomes:
Primary outcome: Hospital admission for major bleeding (in the gut or brain).
Secondary outcome: Hospital admission OR general practice consultation for nose bleeds, coughing up blood, or blood when passing urine.
ONS: Mortality data is necessary for find out who died due to major bleeding.
Funding Source
NIHR advanced Fellowship funded by Health and Care Research Wales https://healthandcareresearchwales.org/
Public Benefit Statement
Research Team
Dr Heather Whitaker, Public Health England
Professor Daniel Farewell, Cardiff University School of Medicine
Professor Julia Hippisley-Cox, University of Oxford
Professor Simon Noble, Cardiff University School of Medicine
Approval Letter
Access Type
Trusted Research Environment (TRE)