NCT00347490已完成4 期
Efficacy and Safety in Hemodialysis With Enoxaparine
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of fibrin / clot formation in dialyser and line grade in 10-point scale
研究概览
简要总结
Primary objective:
To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic hemodialysis
Secondary objective:
To assess safety and tolerability by the number of spontaneously reported adverse events by patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal failure requiring maintenance hemodialysis at least twice a week
- •Has arterio-venous fistula or arterio-venous graft in upper extremities which can apply to blood flow > or = 250ml/min as a vascular access for hemodialysis.
- •Stable hemodialysis prescription at least 1 month before enrollment
- •UFH (Unfractionated Heparin) was prescribed as an anticoagulant in the previous hemodialysis prescription
- •No sign of active infection .
- •Absence of recent cardiovascular complication such as myocardial infarction, DVT (Deep Venous Thrombosis), arterial occlusion, pulmonary embolism, cerebrovascular disease in previous 3 months.
排除标准
- •Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception
- •Patients with any evidence of an active bleeding disorder
- •Contraindication to anticoagulation:
- •Prior history of cerebral hemorrhage at any time
- •Coagulopathy (acquired or inherited)
- •Recent surgery
- •Major surgery such as neurosurgery within the past 3 months
- •Minor surgery such as intraocular surgery within 1 month.
- •Uncontrolled predialytic arterial hypertension (systolic BP > 200 mmHg or diastolic BP > 110 mmHg) at 2 successive readings
- •Impaired hemostasis i.e., known or suspected coagulopathy (acquired or inherited): baseline platelet count <100,000/mm3 in patients without baseline diagnosis of active cancer and undergoing chemotherapy treatment (for patients with diagnosis of cancer and undergoing chemotherapy, baseline platelet count >70,000/mm3); aPTT (activated Partial Thromboplastin Time) 1.5X the laboratory upper limit of normal; or international normalized ratio (INR) >1.5
- •Indication for thrombolytic therapy such as ischemic heart disease, ischemic stroke.
- •Need for a curative treatment of anticoagulant therapy(DVT ,pulmonary embolism, ischemic heart disease)
- •Patients treated with oral anticoagulant therapy within 72 hours prior to inclusion
- •Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
- •Abnormal liver enzyme and total bilirubin within 2 weeks (SGPT, SGOT, total bilirubin above 2 times of Upper normal limit)
- •Known hypersensitivity to heparin or LMWH (Low Molecular Weight Heparin), or pork derived products
- •History of documented episode of heparin or LMWH induced thrombocytopenia and/or thrombosis.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Rate of fibrin / clot formation in dialyser and line grade in 10-point scale
次要结局
- Adverse events
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Ischemia Driven Enoxaparin Therapy in ACS Presenting as Low Risk (IDEAL)Unstable AnginaNCT00518245Canadian Heart Research Centre11
终止
2 期
Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.Nephrotic SyndromeNCT04558892Military Institute od Medicine National Research Institute65
已完成
4 期
Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention (OPTIENOX-PCI)Coronary Artery DiseasePercutaneous Coronary InterventionNCT03145675Peking Union Medical College Hospital378
招募中
不适用
Safety of enoxaparin in patients undergoing curative hepato-biliary-pancreatic cancer surgerySafety of enoxaparin in patients undergoing curative hepato-biliary-pancreatic cancer surgeryJPRN-UMIN000007761Graduate School of Medicine, Osaka University Department of Gastrointestinal Surgery150
已完成
3 期
Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal SurgeryVenous ThromboembolismNCT01308528Cristália Produtos Químicos Farmacêuticos Ltda.243