Table 1

WHO checklist

Data categoryInformation
Primary registry and trial identifying numberISRCTN49677481
Date of registration in primary registry05/03/2018
Secondary identifying numbersNone
Source(s) of monetary or material supportUniversity of Pécs Medical School; Momentum Grant from the Hungarian Academy of Sciences (LP2014-10/2014); Highly Cited Publication Grant (KH 125678) from the National Research Development and Innovation Office; GINOP 2.3.2-15-2016-00048 Stay Alive, EFOP 3.6.2-16-2017-00006 Live Longer, and EFOP-3.6.3-VEKOP-16-2017-00009; Translational Medicine Foundation; and New National Excellence Programme, Ministry of Human Capacities (ÚNKP-17–3-II, ÚNKP-18–3-I)
Primary sponsorNone
Secondary sponsor(s)None
Contact for public queriesZsolt Szakács, MD, szakacs.zsolt@pte.hu
Contact for scientific queriesJudit Bajor, MD, bajor.judit@pte.hu
Public titleInvestigation of haemorheological and haemostatic alterations in coeliac disease and inflammatory bowel disease in comparison with healthy subjects: A case–control study (HERMES)
Scientific titleHaemorheological and haemostatic alterations in coeliac disease and inflammatory bowel disease in comparison with non-coeliac, non-IBD subjects: A case–control study (HERMES)
Countries of recruitmentHungary
Health condition(s) or problem(s) studiedCoeliac disease and inflammatory bowel disease
Intervention(s)Questionnaires (thrombophilia, dietary adherence, disease activity), urine collection (dietary adherence—urine-gluten immunogenic peptide detection), blood collection (haemorheological, haemostatic and immunological tests complemented with routine laboratory panel)
Key inclusion and exclusion criteriaInclusion criteria: adult patients (≥18 years of age) suffering from biopsy-confirmed newly diagnosed or treated coeliac disease (by ESPHGAN, ACG, WGO guidelines), or from inflammatory bowel disease (by ECCO guidelines), and non-coeliac, non-IBD subjects
Exclusion criteria: chronic diseases (chronic kidney diseases, liver cirrhosis, heart failure, active malignant diseases), acute diseases within 2 weeks of inclusion, pregnancy, thrombotic events within 1 year, systematic lupus erythematosus, and use of oral anticoagulants or antiplatelet therapy
Study typeObservational
Date of first enrolment30/5/2018
Target sample sizeFirst phase: 50 coeliac and 50 IBD patients plus control (1–3 for each patient). Second phase: target number is determined by power calculation
Recruitment statusOngoing
Primary outcome(s)Haemorheological test results
Key secondary outcomesHaemostatic test results
  • IBD, inflammatory bowel disease.