A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)

The outcomes of patients developing major bleeding while on oral anticoagulants remain largely unquantified. The objectives of this study were to: (i) describe the burden of major hemorrhage associated with all available oral anticoagulants in terms of proportion of bleeds which are intracranial hem...

Full description

Bibliographic Details
Main Authors: Green, L, Tan, J, Morris, JK, Alikhan, R, Curry, N, Everington, T, Maclean, R, Saja, K, Stanworth, S, Tait, C, MacCallum, P
Format: Journal article
Language:English
Published: Ferrata Storti Foundation (Haematologica) 2018
_version_ 1826259346786353152
author Green, L
Tan, J
Morris, JK
Alikhan, R
Curry, N
Everington, T
Maclean, R
Saja, K
Stanworth, S
Tait, C
MacCallum, P
author_facet Green, L
Tan, J
Morris, JK
Alikhan, R
Curry, N
Everington, T
Maclean, R
Saja, K
Stanworth, S
Tait, C
MacCallum, P
author_sort Green, L
collection OXFORD
description The outcomes of patients developing major bleeding while on oral anticoagulants remain largely unquantified. The objectives of this study were to: (i) describe the burden of major hemorrhage associated with all available oral anticoagulants in terms of proportion of bleeds which are intracranial hemorrhages, in-hospital mortality and duration of hospitalization following major bleeding; (ii) identify risk factors for mortality; and (iii) compare the characteristics of major hemorrhage between cases treated with warfarin and direct oral anticoagulants for the subgroups of patients with atrial fibrillation or venous thromboembolism. This was a multicenter, 3-year prospective cohort study of patients aged ≥18 years on oral anticoagulants who developed major hemorrhage leading to hospitalization. The patients were followed up for 30 days or until discharge or death, whichever occurred first. In total 2,192 patients (47% female, 81% on warfarin, median age 80 years) were reported between October 2013 and August 2016 from 32 hospitals in the UK. Bleeding sites were intracranial (44%), gastrointestinal (33%), and other (24%). The in-hospital mortality was 21% (95% CI: 19%-23%) overall, and 33% (95% CI: 30%-36%) for patients with intracranial hemorrhage. Intracranial hemorrhage, advanced age, spontaneous bleeding, liver failure and cancer were risk factors for death. Compared to warfarin-treated patients, patients treated with direct oral anticoagulants were older and had lower odds of subdural/epidural, subarachnoid and intracerebral bleeding. The mortality rate due to major bleeding was not different between patients being treated with warfarin or direct oral anticoagulants. Major bleeding while on oral anticoagulant therapy leads to considerable hospital stays and short-term mortality.
first_indexed 2024-03-06T18:48:24Z
format Journal article
id oxford-uuid:0f564c9d-c5c2-493c-8a43-7e6c7e51c811
institution University of Oxford
language English
last_indexed 2024-03-06T18:48:24Z
publishDate 2018
publisher Ferrata Storti Foundation (Haematologica)
record_format dspace
spelling oxford-uuid:0f564c9d-c5c2-493c-8a43-7e6c7e51c8112022-03-26T09:50:47ZA three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:0f564c9d-c5c2-493c-8a43-7e6c7e51c811EnglishSymplectic ElementsFerrata Storti Foundation (Haematologica)2018Green, LTan, JMorris, JKAlikhan, RCurry, NEverington, TMaclean, RSaja, KStanworth, STait, CMacCallum, PThe outcomes of patients developing major bleeding while on oral anticoagulants remain largely unquantified. The objectives of this study were to: (i) describe the burden of major hemorrhage associated with all available oral anticoagulants in terms of proportion of bleeds which are intracranial hemorrhages, in-hospital mortality and duration of hospitalization following major bleeding; (ii) identify risk factors for mortality; and (iii) compare the characteristics of major hemorrhage between cases treated with warfarin and direct oral anticoagulants for the subgroups of patients with atrial fibrillation or venous thromboembolism. This was a multicenter, 3-year prospective cohort study of patients aged ≥18 years on oral anticoagulants who developed major hemorrhage leading to hospitalization. The patients were followed up for 30 days or until discharge or death, whichever occurred first. In total 2,192 patients (47% female, 81% on warfarin, median age 80 years) were reported between October 2013 and August 2016 from 32 hospitals in the UK. Bleeding sites were intracranial (44%), gastrointestinal (33%), and other (24%). The in-hospital mortality was 21% (95% CI: 19%-23%) overall, and 33% (95% CI: 30%-36%) for patients with intracranial hemorrhage. Intracranial hemorrhage, advanced age, spontaneous bleeding, liver failure and cancer were risk factors for death. Compared to warfarin-treated patients, patients treated with direct oral anticoagulants were older and had lower odds of subdural/epidural, subarachnoid and intracerebral bleeding. The mortality rate due to major bleeding was not different between patients being treated with warfarin or direct oral anticoagulants. Major bleeding while on oral anticoagulant therapy leads to considerable hospital stays and short-term mortality.
spellingShingle Green, L
Tan, J
Morris, JK
Alikhan, R
Curry, N
Everington, T
Maclean, R
Saja, K
Stanworth, S
Tait, C
MacCallum, P
A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)
title A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)
title_full A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)
title_fullStr A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)
title_full_unstemmed A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)
title_short A three-year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the UK (ORANGE study)
title_sort three year prospective study of the presentation and clinical outcomes of major bleeding episodes associated with oral anticoagulant use in the uk orange study
work_keys_str_mv AT greenl athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT tanj athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT morrisjk athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT alikhanr athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT curryn athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT everingtont athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT macleanr athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT sajak athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT stanworths athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT taitc athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT maccallump athreeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT greenl threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT tanj threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT morrisjk threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT alikhanr threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT curryn threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT everingtont threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT macleanr threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT sajak threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT stanworths threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT taitc threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy
AT maccallump threeyearprospectivestudyofthepresentationandclinicaloutcomesofmajorbleedingepisodesassociatedwithoralanticoagulantuseintheukorangestudy