NCT07213713尚未招募不适用
Evaluation of Anti-Xa Activity in Patients With Severe Obesity After Subcutaneous Injection of Enoxaparin for Antithrombotic Prophylaxis at Two Different Sites.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- The primary outcome is the achievement of both target anti-factor Xa levels at peak, defined as 0.2 to 0.4 IU/mL, and at trough, defined as >0.1 IU/mL.
研究概览
简要总结
To evaluate appropriateness of enoxaparin bioavailability at two different sites of subcutaneous administration (arms or abdomen) in primary or secondary prevention of thromboembolism in a population of patients with severe obesity
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age >18 years,
- •BMI >40 kg/m2
- •indication to primary or secondary thromboprophylaxis (Padua Score > 4), as clinical practice
排除标准
- •indication to full dose anticoagulant,
- •creatinine clearance <30 mL/min (based on Cockcroft-Gault equation using adjusted body weight),
- •pregnant women,
- •low platelet count (<50.000/microL or <100.000/microL plus additional risk factors for bleeding),
- •active bleeding,
- •active gastroduodenal ulcer,
- •severe bleeding diathesis,
- •recent/planned/emergency high bleeding-risk surgery/procedure,
- •major trauma,
- •acute intracranial hemorrhage,
- •bleeding within the three months prior to admission,
- •known hypersensitivity to enoxaparin (e.g. pruritus, urticaria, anaphylactic/anaphylactoid reactions),
- •history of immune mediated heparin-induced thrombocytopenia (HIT),
- •severe uncontrolled hypertension,
- •diabetic or hemorrhagic retinopathy,
- •concurrent administration of subcutaneous drugs (i.e. insulin, GLP-1 receptor agonists, etc.).
结局指标
主要结局
The primary outcome is the achievement of both target anti-factor Xa levels at peak, defined as 0.2 to 0.4 IU/mL, and at trough, defined as >0.1 IU/mL.
时间窗: 24 months
To evaluate appropriateness of enoxaparin bioavailability at two different sites of subcutaneous administration (arms or abdomen) in primary or secondary prevention of thromboembolism in a population of patients with severe obesity
次要结局
未报告次要终点
研究者
De Candia Erica
Prof.ssa Erica De Candia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
相似试验
已完成
3 期
The effectiveness of enoxaparin subcutaneous injection duration on the severity of injection pain in hospitalized patients in orthopedics wardpain.fracture of upper end of tibia , fracture of shaft of tibia , fracture of lower end of tibiaIRCT2016112614333N62Vice chancellor for research, Kermanshah University of Medical Sciences182
已完成
1 期
Enoxamed Study in the Treatment of Acute Coronary SyndromesAcute Coronary SyndromeNCT02152423University of Monastir50
已完成
不适用
Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 PatientsCritical IllnessTherapeutic Drug MonitoringVenous ThromboembolismNCT05926518Rijnstate Hospital62
已完成
4 期
Enoxaparin in Acute Venous Thromboembolic DiseaseVenous ThrombosisNCT00265993Sanofi251
已完成
4 期
Enoxaparin Versus Unfractionated Heparin in Subjects Who Present to the Emergency Department With Acute Coronary Syndrome (RESCUE)Acute Coronary SyndromeNCT00077818Sanofi