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,
Contact for scientific queriesJudit Bajor, MD,
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.