Department of Vascular Medicine, Klinikum Darmstadt GmbH, Darmstadt, Germany; Center for Thrombosis and Hemostasis, University Medical Center, Mainz, Germany.
Private Office for Vascular Diseases, Mannheim, Germany.
J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):553-560.e1. doi: 10.1016/j.jvsv.2017.03.013.
Superficial vein thrombosis (SVT) is a common disease in clinical practice. In terms of pathophysiology and outcomes, the condition is related to venous thromboembolism, bearing a potential for severe thromboembolic complications if it is not treated adequately. A wide range of treatment approaches (including oral and injectable anticoagulants, pain medication, nondrug therapy including compression therapy, and no treatment at all) are applied in clinical practice, but there is sparse information about selection of patients for therapies, current treatment pathways, and drug use as well as outcomes. The INvestigating SIGnificant Health TrendS in the management of Superficial Vein Thrombosis (INSIGHTS-SVT) study aims to close this gap by collecting representative data on the current treatment of SVT.
The observational prospective study of about 1200 patients is carried out by up to 120 clinical and office-based physicians who regularly treat patients with SVT and are capable of conducting appropriate compression ultrasound diagnostics, such as vascular physicians, phlebologists, internists, vascular surgeons, and general practitioners. Patients are eligible for inclusion if they have ultrasound-confirmed acute, isolated SVT of the lower extremities. Documentation about the characteristics of the patients, diagnostics, comorbidities, and medical and nonmedical treatment is collected at baseline, at 10 ± 3 days or at approximately 45 days (depending on treatment), at approximately 3 months, and at approximately 12 months. Patients are requested to fill in quality of life questionnaires (on pain, Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms [VEINES-QOL/Sym], EuroQol-5 Dimension 5-Level [EQ-5D-5L]) at baseline and at approximately 3 months. Interventions are not stipulated by the trial protocol.
The primary efficacy outcome is the incidence of venous thromboembolism at 3 months; the primary safety outcome is the combined incidence of major and clinically relevant bleeding events at 3 months. As quality measures, plausibility checks at data entry, queries based on statistical analyses that focus on outliers and distribution of values, monitoring visits, and adjudication procedures will be applied.
This large study is expected to provide a comprehensive picture of patients with SVT under clinical practice conditions in Germany.
浅静脉血栓形成（SVT）是临床实践中的常见疾病。就病理生理学和结果而言，该疾病与静脉血栓栓塞相关，如果治疗不充分，存在严重血栓栓塞并发症的潜在风险。在临床实践中，应用了广泛的治疗方法（包括口服和注射抗凝剂、止痛药物、非药物治疗，包括压迫治疗，以及根本不治疗），但关于患者治疗选择、当前治疗途径、药物使用和结果的信息很少。INvestigating SIGnificant Health TrendS in the management of Superficial Vein Thrombosis（INSIGHTS-SVT）研究旨在通过收集有关 SVT 当前治疗的代表性数据来填补这一空白。
这项约 1200 例患者的观察性前瞻性研究由多达 120 名经常治疗 SVT 患者的临床和办公室医生进行，他们能够进行适当的压迫超声诊断，如血管科医生、静脉学专家、内科医生、血管外科医生和全科医生。如果患者下肢超声证实为急性、孤立性 SVT，则符合入组条件。在基线、10 ± 3 天或大约 45 天（取决于治疗）、大约 3 个月和约 12 个月时，收集患者特征、诊断、合并症以及医疗和非医疗治疗的记录。患者被要求在基线和大约 3 个月时填写生活质量问卷（疼痛、静脉功能不全流行病学和经济研究生活质量/症状[VEINES-QOL/Sym]、欧洲五维健康量表 5 级[EQ-5D-5L]）。试验方案未规定干预措施。
主要疗效结局是 3 个月时静脉血栓栓塞的发生率；主要安全性结局是 3 个月时主要和临床相关出血事件的联合发生率。作为质量措施，将进行数据输入的合理性检查、基于关注离群值和值分布的统计分析的查询、监测访问和裁决程序。
这项大型研究有望提供德国临床实践条件下 SVT 患者的全面情况。
