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  • Haemorheological and haemostatic alterations in coeliac disease and inflammatory bowel disease in comparison with non-coeliac, non-IBD subjects (HERMES): a case–control study protocol

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Gastroenterology and hepatology
Protocol
Haemorheological and haemostatic alterations in coeliac disease and inflammatory bowel disease in comparison with non-coeliac, non-IBD subjects (HERMES): a case–control study protocol
  1. Zsolt Szakács1,2,3,
  2. Beáta Csiszár1,4,
  3. Péter Kenyeres1,4,
  4. Patrícia Sarlós1,5,
  5. Bálint Erőss3,5,
  6. Alizadeh Hussain1,6,
  7. Ágnes Nagy6,
  8. Balázs Kőszegi7,
  9. Ibolya Veczák5,
  10. Nelli Farkas8,
  11. Emőke Bódis3,
  12. Katalin Márta1,3,
  13. Andrea Szentesi3,
  14. Margit Tőkés-Füzesi9,
  15. Tímea Berki10,
  16. Áron Vincze1,2,5,
  17. Kálmán Tóth1,4,
  18. Péter Hegyi1,2,3,
  19. Judit Bajor2,5
  1. 1 János Szentágothai Research Center, University of Pécs, Pécs, Hungary
  2. 2 Clinical Medicine Doctoral School, University of Szeged, Szeged, Hungary
  3. 3 Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary
  4. 4 Division of Cardiology and Angiology, First Department of Medicine, University of Pécs, Pécs, Hungary
  5. 5 Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
  6. 6 Division of Hematology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
  7. 7 Department of Biochemistry and Medical Chemistry, Medical School, University of Pécs, Pécs, Hungary
  8. 8 Institute of Bioanalysis, Medical School, University of Pécs, Pécs, Hungary
  9. 9 Department of Laboratory Medicine, Medical School, University of Pécs, Pécs, Hungary
  10. 10 Department of Immunology and Biotechnology, Medical School, University of Pécs, Pécs, Hungary
  1. Correspondence to Dr Péter Hegyi; p.hegyi{at}tm-centre.org

Abstract

Introduction Haemorheological and haemostatic changes predispose to the development of arterial and venous thrombotic events; however, limited information is available on the status of these changes in coeliac disease (CeD) and inflammatory bowel disease (IBD). In this study, we aim to describe the haemorheological and haemostatic profiles of CeD and IBD patients in a Hungarian cohort of patients to investigate whether any alterations contribute to elevated thrombotic risk.

Methods and analysis This is a case–control study involving newly diagnosed and followed CeD and IBD patients with age-matched and sex-matched non-CeD, non-IBD subjects with an allocation ratio of 1:1:1.

After informed consent is obtained, a detailed medical history will be collected, including venous and arterial thrombotic risk factors and medications. Symptoms in CeD patients will be assessed with the Gastrointestinal Symptoms Rating Scale, and disease activity in IBD patients will be determined by disease-specific scores. Dietary adherence will be assessed among CeD patients with a thorough interview together with a measurement of self-reported adherence, dietary knowledge and urine analysis (detection of gluten immunogenic peptides). In addition to routine laboratory parameters, haemorheological (ie, erythrocyte deformability and aggregation, viscosity of whole blood and plasma) and haemostatic parameters (eg, protein C, protein S and antithrombin) with immunological indicators (ie, coeliac-specific serology and antiphospholipid antibodies) will be measured from venous blood for every participant.

Primary and secondary outcomes will be haemorheological and haemostatic parameters, respectively. Univariate and multivariate statistics will be used to compare CeD and IBD patients to control subjects. Subgroup analysis will be performed by disease type in IBD, (Crohn’s disease and ulcerose colitis), dietary adherence in CeD, and disease activity in IBD and CeD.

Ethics and dissemination The study was approved by the Regional and Local Research Ethics Committee, University of Pécs (Ref. No. 6917). Findings will be disseminated at research conferences and in peer-reviewed journals.

Trial registration number ISRCTN49677481.

  • inflammatory bowel disease
  • coeliac disease
  • thrombosis
  • haemorheology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-026315

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    Footnotes

    • PH and JB contributed equally.

    • Contributors JB is the Principal Investigator. ZS is the Trial Co-ordinator. ZS, PH, JB, ÁV and KT conceptualised the study, drafted and revised this manuscript. NF and EB planned and drafted the statistical analysis. PS, JB, BE and ÁV provided us with special expertise in the management of coeliac disease and inflammatory bowel patients. BC and PK are performing the haemorheological measurements and interpreting the results. AH, ÁN, TB and MT-F provided us with special expertise in hemostatic and immunological measurements. BK is contributing significantly to the biochemical analyses. IV planned and is carrying out the dietary assessment of the coeliac patients. KM, AS, ZS and PH are responsible for data management, administrative co-ordination and biological sampling; they drafted and revised the manuscript. All the authors have read and approved the final manuscript.

    • Funding The project is non-industry-funded. Study and centre costs are covered by the University of Pécs Medical School, by a Momentum Grant from the Hungarian Academy of Sciences (LP2014-10/2014), by a Highly Cited Publication Grant (KH 125678) from the National Research Development and Innovation Office, by GINOP 2.3.2-15-2016-00048 Stay Alive, EFOP-3.6.2-16-2017-0006, and EFOP-3.6.3-VEKOP-16-2017-00009; and by the Translational Medicine Foundation. In addition, this project is supported by the ÚNKP-17-3-II and ÚNKP-18-3-I New National Excellence Programme, Ministry of Human Capacities. Funders have no influence on preparations, course, interpretation, or publication of results.

    • Competing interests None declared.

    • Ethics approval The study was approved by the Regional and Local Research Ethics Committee, University of Pécs (Ref No 6917).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.