Resolution Enhancement by a Supplemental Obstruction Lessening Venoactive Drug for Eight Weeks in Deep Vein Thrombosis: A Pilot Study to Evaluate if Hydroxyethylrutoside Reduces the Risk of Post-Thrombotic Syndrome in Patients With DVT.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Residual Vein Obstruction
研究概览
简要总结
The RESOLVE-DVT study is a randomized single-center pilot study to determine the effects of hydroxyethylrutoside (Venoruton) on aspects of deep vein thrombosis (DVT) resolution associated with post-thrombotic syndrome (PTS). Based on these results, the investigators will estimate its potential as a preventive therapy for PTS.
Eligible consenting patients who develop an acute, objectively confirmed DVT will be randomized and equally allocated to two trial arms, either the treatment group (Venoruton tablet 500 mg twice daily) or the control group (usual care). The pilot trial consists of 5 study contacts over 12 weeks at which outcome assessment is performed: inclusion, 1 week, 4 weeks, 8 weeks, 12 weeks. Treatment allocation is masked for outcome assessors, but not for patients.
详细描述
Rationale: After a DVT, one in three patients develops PTS of the affected leg, despite anticoagulant treatment and elastic compression therapy (ECT) in the acute phase of DVT. Considering the major societal burden associated with PTS, supplementation of current prevention with an effective pharmacotherapeutic therapy would be of high value. Since the pathogenesis of PTS is mediated through persistent inflammation during thrombus resolution, causing damage to the vein wall resulting in venous insufficiency, the venoactive flavonoids with their vasoprotective and anti-inflammatory properties provide an excellent candidate. As investigational medicinal product, the highly effective flavonoid Hydroxyethylrutoside (Venoruton) was chosen.
Objective: To assess the effect of Venoruton on PTS-associated aspects of DVT resolution.
Study design: A single-center, randomized, controlled, pilot study.
Study population: Adults presenting themselves at the emergency department (ED) with a first, acute, proximal DVT of the lower extremity. Inclusion will be performed within 48 hours after diagnosis of DVT.
Intervention: Administration of 500 mg Venoruton twice daily for 8 weeks following DVT, in addition to standard treatment by ECT and anticoagulant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
While patients are aware of their treatment allocation, the physicians (incl. radiologist) and researchers are not, as to provide unbiased outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, defined as ≥ 18 years of age
- •Objectively confirmed DVT by DUS
- •Proximal DVT, defined as iliofemoropopliteal venous thrombosis
- •Acute DVT, defined as having symptoms for ≤ 7 days at presentation
- •Willing and able to give written informed consent
排除标准
- •Previous DVT
- •Bilateral DVT
- •Pre-existent chronic venous insufficiency (CEAP-criteria C ≥ 3)
- •Active malignancy, inflammatory disease (e.g. rheumatoid arthritis), or immunosuppressive therapy
- •Current pregnancy or breast feeding
- •Indication for therapeutic thrombolysis
- •Contra-indication for DOAC
研究组 & 干预措施
Treatment group
Hydroxyethylrutoside oral tablet twice daily for 8 weeks starting at the time of randomization, in addition to usual care.
干预措施: Hydroxyethylrutoside (Drug)
结局指标
主要结局
Residual Vein Obstruction
时间窗: At 12 weeks
Transversal vein diameter ≥2mm on duplex-ultrasound during full compression, which is assessed by a radiologist blinded for study allocation. A secondary assessment based on acquired images will be performed by an independent expert radiologist, again blinded for study allocation.
次要结局
- Levels of circulating biomarkers(At time of inclusion, 1 week, 4 weeks, 8 weeks and 12 weeks)
- Clinical sign severity(At time of inclusion, 1 week, 4 weeks, 8 weeks and 12 weeks)
- Symptom severity(At time of inclusion, 4 weeks and 12 weeks)
- VEINS Quality of Life/Symptoms (VEINES-QOL/Sym)(At time of inclusion, 4 weeks and 12 weeks)
- Short Form 36 Health Survey (SF-36)(At time of inclusion, 4 weeks and 12 weeks)
- Euro Quality of Life 5D (EQ-5D)(At time of inclusion, 4 weeks and 12 weeks)