Edelgard Lindhoff-Last1, Eva Herrmann, Simone Lindau, Stavros Konstantinides, Oliver Grottke, Ulrike Nowak-Goettl, Jessica Lucks, Barbara Zydek, Christian von Heymann, Ingvild Birschmann, Ariane Sümnig, Jan Beyer-Westendorf, Sebastian Schellong, Patrick Meybohm, Andreas Greinacher. 1. Coagulation Center and Research Center, Cardioangiology Center Bethanien Hospital (CCB), Frankfurt/Main; Institute of Biostatistics und Mathematical Modelling, Goethe University, Frankfurt; Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt/Main; Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz; Department of Anesthesiology, RWTH Aachen University Hospital, Aachen; Department of Clinical Chemistry, Thrombosis and Hemostasis Unit, University Hospital of Kiel and Lübeck, Kiel; Research Center of the Cardioangiology Center Bethanien Hospital (CCB), Frankfurt/Main; Department of Anesthesiology, Intensive Care and Emergency Medicine and Pain Therapy, Vivantes Klinikum im Friedrichshain, Berlin; Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center, Ruhr University Bochum, Bochum; Department of Immunology and Transfusion medicine, University Medicine Greifswald, Greifswald; Thrombosis Research Unit, Center for Internal Medicine 1, Department of Hematology, University Hospital Dresden, Dresden, Germany, and Department of Haematology and Oncology, Kings College London, England; Medical Department 2, Municipal Hospital Dresden-Friedrichstadt, Dresden; Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt am Main, and Department of Anesthesiology, University Hospital Würzburg, Würzburg; Department of Immunology and Transfusion Medicine, University Medicine Greifswald, Greifswald.
Abstract
BACKGROUND: Few data have been published to date on outcomes after the common clinical experience of severe hemorrhage in orally anticoagulated patients. METHODS: A prospective, multicenter observational study was carried out to investigate outcomes and management in a series of consecutive patients who sustained a severe hemorrhage under treatment with vitamin K antagonists (VKA) or direct oral anticoagulant drugs (DOAC). The primary endpoint was in-hospital death up to and including day 30 after hospital admission. The secondary endpoints were the duration of bleeding, in-hospital death due to hemorrhage (as defined by the study physician examining the patient's records), the use of antagonists, the extent of supportive measures used to stop the hemorrhage, and an assessment of causality. Consecutive patients were recruited until a predefined number of patients was reached in both groups. RESULTS: Among 193 patients with severe hemorrhage, 97 had been taking a VKA, and 96 had been taking a DOAC. 13.0 % (95% confidence interval [8.6; 18.5]; 25/193) of the overall group patients died in the first 30 days after hospital admission, including 17.5% ([10.6; 26.6]; 17/97) in the VKA group and 8.3% ([3.7; 15.8]; 8/96) in the DOAC group (p = 0.085). The median duration of bleeding was 19.8 hours in the VKA group and 27.8 hours in the DOAC group (p = 0.632). The in-hospital mortality due to hemorrhage was higher in the VKA group than in the DOAC group (15.5% [15/97] versus 4.2% [4/97]; p = 0.014). Only the use of prothrombin complex concentrates (PCCs) lowered the median duration of hemorrhage in the two patient groups. In 35% (68/193) of the patients, the hemorrhage was caused by an external influence, most commonly a fall. CONCLUSION: The in-hospital mortality was higher among patients treated with VKA than among patients treated with DOAC, although the difference failed to reach statistical significance.
BACKGROUND: Few data have been published to date on outcomes after the common clinical experience of severe hemorrhage in orally anticoagulated patients. METHODS: A prospective, multicenter observational study was carried out to investigate outcomes and management in a series of consecutive patients who sustained a severe hemorrhage under treatment with vitamin K antagonists (VKA) or direct oral anticoagulant drugs (DOAC). The primary endpoint was in-hospital death up to and including day 30 after hospital admission. The secondary endpoints were the duration of bleeding, in-hospital death due to hemorrhage (as defined by the study physician examining the patient's records), the use of antagonists, the extent of supportive measures used to stop the hemorrhage, and an assessment of causality. Consecutive patients were recruited until a predefined number of patients was reached in both groups. RESULTS: Among 193 patients with severe hemorrhage, 97 had been taking a VKA, and 96 had been taking a DOAC. 13.0 % (95% confidence interval [8.6; 18.5]; 25/193) of the overall group patientsdied in the first 30 days after hospital admission, including 17.5% ([10.6; 26.6]; 17/97) in the VKA group and 8.3% ([3.7; 15.8]; 8/96) in the DOAC group (p = 0.085). The median duration of bleeding was 19.8 hours in the VKA group and 27.8 hours in the DOAC group (p = 0.632). The in-hospital mortality due to hemorrhage was higher in the VKA group than in the DOAC group (15.5% [15/97] versus 4.2% [4/97]; p = 0.014). Only the use of prothrombin complex concentrates (PCCs) lowered the median duration of hemorrhage in the two patient groups. In 35% (68/193) of the patients, the hemorrhage was caused by an external influence, most commonly a fall. CONCLUSION: The in-hospital mortality was higher among patients treated with VKA than among patients treated with DOAC, although the difference failed to reach statistical significance.
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