EUCTR2006-000152-41-DK进行中（未招募）1 期
A multicenter, Randomized, Double Blind, Double Dummy, Parallel Group, Dose Ranging Study of subcutaneous SR123781A with an Enoxaparin calibrator arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement surgery - DRIVE
Sanofi Synthelabo Recherche0 个研究点目标入组 1,020 人开始时间: 2006年3月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,020
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
- •Age = 18 years
- •Undergoing elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed = 6 months prior to study entry
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •Related to study methodology
- •o Pregnant or nursing women, or women of childbearing potential who are not
- •using an effective contraceptive method and who do not have a negative
- •pregnancy test performed immediately before randomization
- •o Treatment with any investigational product or investigational device in the last
- •30 days prior to randomization
- •o Current addictive disorders that could interfere with study participation
- •o Known progressive malignant disease
- •o Ischemic stroke, myocardial infarction, any major orthopedic surgeryin the last 3 months
- •o Clinical signs or symptoms of DVT or PE within the last 12 months or
- •symptoms of post phlebitic syndrome
- •o Treatment with other antithrombotic agents within 7 days prior to surgery
- •o Serum creatinine > 2 mg/dL (180 µmol/L) in a well hydrated patient
- •o Significant anemia (Hb < 10 g/dL)
- •o Known sensitivity to iodine or contrast dyes
- •o Use of any contraindicated drug that cannot be combined with the injection of
- •contrast medium, e.g. antihyperglycemic drug metformin
- •Related to the active calibrator
- •o Any contra-indication or history of hypersensitivity to UFH or LMWH
- •o Past or present bleeding disorder
- •o Active or recent (<3 months) significant bleeding, including gastrointestinal
- •bleeding or peptic ulcer
- •o Uncontrolled arterial hypertension
- •o Any history of hemorrhagic stroke
- •o Known structural damage or other pathologic process involving the central
- •nervous system
- •o Recent (<3 months) trauma, major surgery, ophthalmic surgery or parenchymal
- •organ biopsy
- •o Thrombocytopenia
- •o History of heparin induced thrombocytopenia
研究者
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