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thrombEVAL - A study to investigate the medical care of patients on oral anticoagulants

  • Study directors: Univ.-Prof. Dr. med. Philipp Wild, M.Sc.
                       (Principal Investigator)
                        Univ.-Prof. Dr. med. Thomas Münzel
                       (Co-Principal Investigator)
  • ClinicalTrials.gov - ID-Nr.: NCT01809015

Brief summary

The thrombEVAL study investigates the medical care of patients on oral anticoagulation. Oral anticoagulants are used in everyday clinical practice for the treatment and prevention of thrombotic and embolic events; this affects approximately 900,000 people in Germany. The number of patients requiring this therapy will continue to increase in the future due to demographic change. The increasing multimorbidity of elderly patients and availability of new therapeutic options make therapy with oral anticoagulants a complex challenge in everyday clinical practice. The most common complications of oral anticoagulation are the occurrence of bleeding as well as thrombosis and embolism. These complications pose a high health risk to patients and result in significant healthcare costs. However, the scientific evidence for established therapy with the vitamin K antagonist (VKA) phenprocoumon, which is mainly used for oral anticoagulation in Germany, is very limited. The goal of the thrombeval study program is to fill this knowledge gap and provide scientific data that will identify starting points for optimization of existing care. For this purpose, academic partners as well as public health and health policy partners have formed a network to jointly support the state lead project thrombEVAL (www.gesundheitswirtschaft.rlp.de/massnahmen/landesleitprojekte). The study program includes a total of 3 studies: Evaluation of the quality of anticoagulation in standard medical care (thrombEVAL1) and in a telemedicine-based coagulation service (thrombEVAL2) and stakeholder analysis among working physicians and anticoagulated patients in Rhineland-Palatinate (thrombEVAL3). Based on the study data, determinants of successful, i.e. complication-free, anticoagulation should be identified, taking into account the individual risk profile, in order to develop new concepts for individualized therapy in clinical practice. In addition to the established therapy with VKA, this has important implications for therapy with the so-called "new oral anticoagulants" (NOAC) in clinical practice.

  • For more information about the thrombeval study program, please visit: www.thrombEVAL.de

Study design

thrombEVAL1: Multicenter prospective cohort study

 

thrombEVAL2: Monocentric prospective cohort study

 

thrombEVAL3: Monocentric cross-sectional survey

Official title

thrombEVAL – A study program on “the medical care of patients on oral anticoagulation”

Study start

1st quarter of 2011

Study end

1st quarter of 2018

Sample size

thrombEVAL1: 2,011 study participants

 

thrombEVAL2: 760 study participants

 

thrombEVAL3: approx. 11,700 physicians and approx. 2,000 patients

Study centers

21

Status

thrombEVAL1: ongoing follow up (year 1-5 after inclusion using computer-assisted telephone interview; endpoint research and validation)

 

thrombEVAL2: follow-up ended

 

thrombEVAL3: reached end of study

Steering committee

Manfred Beutel, Mainz, Christine Espinola-Klein, Mainz, Stavros Konstantinides, Mainz, Karl J. Lackner, Mainz, Thomas Münzel, Mainz, Helmut Schinzel, Mainz, Philipp Wild, Mainz

Study manager

Jürgen Prochaska

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