Project details


Analysis of patients with bleeding emergencies requiring prothrombin complex concentrates.

bleeding hematology, cancer, critical care, outcome anticoagulants

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
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:
Research question / problem definition
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.
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.
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.
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