THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,175
- 试验地点
- 2
- 主要终点
- Imaging confirmed lower limb deep vein thrombosis (DVT) with or without symptoms, or pulmonary embolism (PE) with symptoms within 90 days of varicose vein treatment.
研究概览
简要总结
Endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. Varicose veins are enlarged veins close to the surface of the skin. They are connected to the bigger deeper veins in the leg (known as deep veins). Because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. Blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. A clot in the leg can cause swelling, pain, and other long-term problems. If a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening.
Varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures.
This study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.
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
- Single (Outcomes Assessor)
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
- •Adults (>18 years)
- •Scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia
- •Treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue
排除标准
- •Clinical indication for therapeutic anticoagulation e.g., atrial fibrillation
- •Previous personal or first-degree relative history of VTE
- •Thrombophilia
- •Female patients of childbearing potential who have a positive pregnancy test
- •A history of allergy to heparins or direct oral anticoagulants
- •A history of heparin-induced thrombocytopenia
- •Inherited and acquired bleeding disorders
- •Evidence of active bleeding
- •Concomitant major health problems such as active cancer and chronic renal and/or liver impairment
- •Known thrombocytopenia (platelets known to be less than 50 x 109
- •Surgery or major trauma in the previous 90 days
- •Recent ischemic stroke in the previous 90 days
- •Inability to provide consent
研究组 & 干预措施
Compression therapy + single dose of low-molecular weight heparin at time of procedure
A single prophylactic dose of low molecular weight heparin (LMWH) (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) will be prescribed as per standard practice and administered in accordance with the relevant Summary of Product Characteristics (SmPC), manufacturer's recommendations and instructions for use.
干预措施: Dalteparin Sodium (Drug)
Compression therapy + single dose of low-molecular weight heparin at time of procedure
A single prophylactic dose of low molecular weight heparin (LMWH) (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) will be prescribed as per standard practice and administered in accordance with the relevant Summary of Product Characteristics (SmPC), manufacturer's recommendations and instructions for use.
干预措施: Tinzaparin Sodium (Drug)
Compression therapy + single dose of low-molecular weight heparin at time of procedure
A single prophylactic dose of low molecular weight heparin (LMWH) (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) will be prescribed as per standard practice and administered in accordance with the relevant Summary of Product Characteristics (SmPC), manufacturer's recommendations and instructions for use.
干预措施: Enoxaparin Sodium (Drug)
Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
An extended duration of LMWH (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) or an extended duration of a direct oral anticoagulant (DOAC) (e.g., rivaroxaban, apixaban, dabigatran etexilate) will be prescribed as per current local practice and administered in accordance with the relevant SmPC, manufacturer's recommendations and instructions for use. The duration of this must be at least 7 days, but can be in line with local practice i.e., 7, 10 or 14 days.
干预措施: Apixaban (Drug)
Compression therapy alone
Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
An extended duration of LMWH (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) or an extended duration of a direct oral anticoagulant (DOAC) (e.g., rivaroxaban, apixaban, dabigatran etexilate) will be prescribed as per current local practice and administered in accordance with the relevant SmPC, manufacturer's recommendations and instructions for use. The duration of this must be at least 7 days, but can be in line with local practice i.e., 7, 10 or 14 days.
干预措施: Dalteparin Sodium (Drug)
Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
An extended duration of LMWH (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) or an extended duration of a direct oral anticoagulant (DOAC) (e.g., rivaroxaban, apixaban, dabigatran etexilate) will be prescribed as per current local practice and administered in accordance with the relevant SmPC, manufacturer's recommendations and instructions for use. The duration of this must be at least 7 days, but can be in line with local practice i.e., 7, 10 or 14 days.
干预措施: Tinzaparin Sodium (Drug)
Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
An extended duration of LMWH (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) or an extended duration of a direct oral anticoagulant (DOAC) (e.g., rivaroxaban, apixaban, dabigatran etexilate) will be prescribed as per current local practice and administered in accordance with the relevant SmPC, manufacturer's recommendations and instructions for use. The duration of this must be at least 7 days, but can be in line with local practice i.e., 7, 10 or 14 days.
干预措施: Rivaroxaban (Drug)
Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
An extended duration of LMWH (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) or an extended duration of a direct oral anticoagulant (DOAC) (e.g., rivaroxaban, apixaban, dabigatran etexilate) will be prescribed as per current local practice and administered in accordance with the relevant SmPC, manufacturer's recommendations and instructions for use. The duration of this must be at least 7 days, but can be in line with local practice i.e., 7, 10 or 14 days.
干预措施: Enoxaparin Sodium (Drug)
Compression therapy + single dose of LMWH at time of procedure + extended course of LMWH or DOAC
An extended duration of LMWH (e.g., dalteparin sodium, tinzaparin sodium, enoxaparin sodium) or an extended duration of a direct oral anticoagulant (DOAC) (e.g., rivaroxaban, apixaban, dabigatran etexilate) will be prescribed as per current local practice and administered in accordance with the relevant SmPC, manufacturer's recommendations and instructions for use. The duration of this must be at least 7 days, but can be in line with local practice i.e., 7, 10 or 14 days.
干预措施: Dabigatran Etexilate (Drug)
结局指标
主要结局
Imaging confirmed lower limb deep vein thrombosis (DVT) with or without symptoms, or pulmonary embolism (PE) with symptoms within 90 days of varicose vein treatment.
时间窗: 90 days
The rate of lower limb DVT with or without symptoms, or PE with symptoms within 90 days of varicose vein treatment.
次要结局
- Mortality rates in each group(90 days)
- Lower limb DVT without symptoms(21 - 28 days)
- Lower limb DVT with symptoms(90 days)
- PE with symptoms(90 days)
- Comparisons of quality of life at 7- and 90-days post-procedure(90-days)
- Cost-effectiveness of providing pharmacological thromboprophylaxis(90 days)
- Exploratory analyses to assess how well a VTE risk assessment tool predicts VTE outcome(90 days)