EUCTR2006-004676-12-DE进行中（未招募）不适用
A randomized, double-blind, multi-center comparison of the efficacy and safety of certoparin (3000 U anti-Xa o.d.) with unfractionated heparin (5000 IU t.i.d.) in the prophylaxis of thromboembolic events in acutely ill medical patients
ovartis Pharma GmbH0 个研究点目标入组 3,200 人开始时间: 2007年1月25日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Hospitalized medical patients 70 years of age or older
- •2.Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
- •3.written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.immobilization longer than 3 days prior to randomization
- •2.prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
- •3.expected major surgical or invasive procedure within 3 weeks following randomization (e.g. thoracic surgery; but permitted are: e.g. uncomplicated angiography, gastroscopy)
- •4.patients with severe sepsis or need for ventilatory support (permitted are CPAP, oxygen via mask etc.)
- •5.LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
- •6.immobilization due to cast or fracture
- •7.indication for anticoagulatory or thrombolytic therapy
- •8.life expectancy < 6 months or illness with very high acute mortality (> 30%)
- •9.acute symptomatic DVT / PE
- •10.known hypersensitivity to any of the study drugs or drugs with similar chemical structures
- •11.Acute or history of heparin induced thrombocytopenia type II (HIT II)
- •12.hemorrhagic diathesis, deficiency of coagulation factors, severe thrombocytopenia
- •13.acute or history of non-hemorrhagic stroke (< 3 months); hemorrhagic stroke or intracranial bleeding (< 12 months)
- •14.acute or ongoing intracranial disease, e.g. cerebral aneurysm
- •15.high risk of gastrointestinal bleeding
- •16.spinal or epidural anesthesia, lumbar punction within the last 12 hours
- •17.uncontrolled hypertension, RRdiast. > 105 mmHg
- •18.severe liver disease
- •19.severe renal dysfunction (estimated GFR < 30 ml/min, Cockcroft-Gault or MDRD formula)
- •20.acute endocarditis
- •21.known active retinopathy, intravitreal or other intraocular bleeding
- •22.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •23.Subjects unlikely to comply with the requirements of the protocol.
研究者
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