NL-OMON55205招募中3 期
Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial - SAFE-SSPE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Informed Consent as documented by signature
- •2) Age >=18 years
- •3) Objective diagnosis of symptomatic or asymptomatic isolated SSPE
排除标准
- •1) Presence of leg deep vein thrombosis (DVT) or upper extremity DVT
- •(subclavian vein or above)
- •2) Active cancer, defined as cancer treated with surgery, chemotherapy,
- •radiotherapy, or palliative care during the last 6 months
- •3) >=1 prior episode of unprovoked VTE (absence of a transient or permanent risk
- •4) Clinical instability (systolic blood pressure <100 mm Hg or arterial
- •oxygen saturation <92% at ambient air) at the time of presentation
- •5) Active bleeding or at high risk of bleeding
- •6) Severe renal failure (creatinine clearance <30ml/min)
- •7) Severe liver insufficiency (Child-Pugh B or C)
- •8) Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
- •9) Known hypersensitivity to rivaroxaban
- •10) Need for therapeutic anticoagulation for another reason
- •11) Therapeutic anticoagulation for >72 hours for any reason at the time of
- •12) Hospitalized for >72 hours prior to the diagnosis of isolated SSPE
- •(hospital-acquired VTE)
- •13) Known pregnancy or breast feeding (pregnancy test to be performed for women
- •of childbearing potential)
- •14) Lack of safe contraception in women of childbearing potential
- •15) Refusal or inability to provide informed consent
- •16) Prior enrolment in this trial
研究者
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