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Project properties
Title | Analysis of patients with bleeding emergencies requiring prothrombin complex concentrates. |
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Keywords | bleeding hematology, cancer, critical care, outcome anticoagulants |
Researchers |
R. Abdoellakhan N. Khorsand K. Meijer |
Nature of the research | Creation and analysis of a database for an ongoing multicenter interventional study |
Fields of study | pharmacology haematology |
Background / introduction |
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Millions of patients worldwide receive anticoagulants for treatment of atrial fibrillation or venous thromboembolism. Although highly effective, an important side effect is the increased risk of bleeding [1]. Major bleeds often require immediate reversal of the anticoagulant effect. Prothrombin complex concentrates (PCC) reverse the anticoagulant effect of vitamin k antagonists (VKA) [2]. We are currently performing a multicentre RCT comparing a fixed dose of 1000 IU PCC versus the variable dose based on bodyweight and INR [3]. In this project we want to define the patients and compare the population with those described in published phase 3 or 4 studies. see also: www.proper3.nl |
Research question / problem definition |
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The aim of the study is to describe the risk profile and types of bleeding of patients on VKA therapy having bleeds that necessitate the use of PCC. |
Workplan |
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The student will collect data of patients included in the PROPER3 study from several Dutch hospitals. The data is entered in a database, after which the student performs analysis of the data to describe the population. Following literature study, the student compares the study population to those described in published trials. Writing a protocol and formulating a statistical analysis approach is part of the project. Finally a report is written in which scientific writing is introduced. The patient dataset will provide the student broad understanding of how anticoagulation-related bleeds of various medical specialisms occurs and how they are treated in a number of different Dutch hospitals. |
References |
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1. Deitelzweig S, Farmer C, Luo X, et al. Risk of major bleeding in patients with non-valvular atrial fibrillation treated with oral anticoagulants: a systematic review of real-world observational studies. Curr Med Res Opin 2017;33:1583-94 2. Sarode R, Milling TJ Jr, Refaai MA, et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation 2013;128:1234-43 3. Abdoellakhan R. Bleeding in users of vitamin K-antagonists: a fixed or variable dose protrombin complex concentrate? Ned Tijdschr Geneeskd 2016;160:D388. |