BLEED-AF

• Research type

  Research Study

• Full title

  Evaluation of biomarkers of bleeding in patients with AF (BLEED-AF)

• IRAS ID

  301851

• Contact name

  Diana Gorog

• Contact email

  d.gorog@nhs.net

• Sponsor organisation

  East and North Hertfordshire NHS Trust

• Duration of Study in the UK

  8 years, 0 months, 1 days

• Research summary

  This study aims to identify patients who are at increased risk of bleeding when they take a blood thinner. Most patients with an irregular heart beat, called Atrial Fibrillation (AF) are at increased risk of forming blood clots inside the body, which can break off and cause stroke. To reduce the risk of stroke, patients are given medications to thin their blood. These are called anticoagulants and include medications such as warfarin, apixaban, rivaroxaban, amongst others. Thinning the blood, however, makes that person more prone to bleeding, which can be fatal.
  Whilst most people have no major bleeding complications, some few people on blood thinners can have life-threatening bleeding. There is currently no blood test available to identify which patients are at greater risk of bleeding than others.
  Before starting blood thinning medications, doctors use risk scores to identify patients who are at the highest risk of stroke or bleeding. Currently, these risk scores only use clinical risk factors (such as age or high blood pressure) in their formulas. The scores, however, are not very accurate and cannot easily tell apart patients who are mostly at risk of stroke compared to those patients who are mostly at risk of bleeding.

  This study will look into patients with AF who are taking blood thinning medications. The thickness of their blood and certain blood molecules (biomarkers) will be measured from a small blood sample, taken on 4 occasions over the course of 3 months. The patients will then be followed up for 5 years by telephone to check for bleeding problems.

  By finding out ways to more accurately identify patients with the highest risk of bleeding, doctors in the future, will be able to tailor blood thinning treatment to an individual -so called “personalised medicine”- thus avoiding unnecessary bleeding complications.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  21/NW/0263

• Date of REC Opinion

  28 Sep 2021

• REC opinion

  Further Information Favourable Opinion