János Szentágothai Research Center, University of Pécs, Pécs, Hungary.
Clinical Medicine Doctoral School, University of Szeged, Szeged, Hungary.
BMJ Open. 2019 Mar 23;9(3):e026315. doi: 10.1136/bmjopen-2018-026315.
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.
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.
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.
ISRCTN49677481.
血液流变学和止血变化使动脉和静脉血栓事件的发生倾向增加；然而，关于这些变化在腹腔疾病（CeD）和炎症性肠病（IBD）中的状态，信息有限。在这项研究中，我们旨在描述匈牙利队列中 CeD 和 IBD 患者的血液流变学和止血特征，以研究是否有任何改变导致血栓形成风险增加。
这是一项病例对照研究，涉及新诊断和随访的 CeD 和 IBD 患者，以及年龄和性别匹配的非 CeD、非 IBD 对照者，分配比例为 1:1:1。在获得知情同意后，将收集详细的病史，包括静脉和动脉血栓形成危险因素和药物。CeD 患者的症状将通过胃肠道症状评分量表进行评估，IBD 患者的疾病活动将通过特定疾病评分确定。CeD 患者的饮食依从性将通过彻底的访谈以及自我报告的依从性、饮食知识和尿液分析（检测谷蛋白免疫肽）来评估。除了常规实验室参数外，还将从静脉血中测量血液流变学（即红细胞变形性和聚集性、全血和血浆粘度）和止血参数（如蛋白 C、蛋白 S 和抗凝血酶）以及免疫指标（即腹腔疾病特异性血清学和抗磷脂抗体）。
主要和次要结局分别为血液流变学和止血参数。将使用单变量和多变量统计方法将 CeD 和 IBD 患者与对照者进行比较。在 IBD 中（克罗恩病和溃疡性结肠炎），CeD 中的饮食依从性，以及 IBD 和 CeD 中的疾病活动，将进行疾病类型亚组分析。
该研究得到了佩奇大学地区和地方研究伦理委员会的批准（参考号：6917）。研究结果将在研究会议和同行评议期刊上发表。
ISRCTN49677481。
