EUCTR2008-004539-39-LV进行中（未招募）不适用
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous hromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active-Controlled Open Label Study
ThromboGenics N.V0 个研究点目标入组 300 人开始时间: 2008年10月14日最近更新:
适应症
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
- 300
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. Male or female patients aged > 18 and < 80 years old
- •2. Female patients should be post menopausal
- •3. Patients undergoing primary elective total knee replacement surgery
- •4. Written informed consent obtained from the patient (or legally acceptable
- •representative) prior to inclusion in the study
- •5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests
- •and other study procedures
- •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
- •1. Body weight < 50 kg or > 100 kg
- •2. Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of
- •3. Confirmed symptomatic deep vein thrombosis or pulmonary embolism within
- •the past year
- •4. Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h
- •after surgery or during the entire study
- •5. Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg)
- •6. History of intracranial or intraocular bleeding. History of gastrointestinal and/or
- •endoscopically verified ulcer disease within the past year
- •7. Patients at increased risk of bleeding because of personal history of increased
- •bleeding tendency or any other condition that in the opinion of the investigator
- •increases risk of bleeding (e.g. documented angiodysplasia, recurrent
- •gastrointestinal ulcer)
- •8. Clinical laboratory evidence at screening of anemia (haemoglobin level < 10.0
- •g/dL) or thrombocytopenia (platelet count < 100X103/µL) or prolonged activated
- •partial thromboplastin time (APTT) or prothrombin time (PT) as per local lab
- •9. Excessive peroperative bleeding and/or active significant postoperative wound
- •bleeding as per the investigator’s judgement
- •10. Antiplatelet agents other than low dose aspirin < 160mg. The use of
- •antithrombotic therapy within 7 days before surgery except for a
- •thromboprophylactic dose of LMWH or unfractionated heparin. The use of
- •intermittent pneumatic compression.
- •11. Patients who require long-term anticoagulant treatment for a comorbid
- •12. History of significant adverse reaction (e.g. Heparin- or LMWH- induced
- •thrombocytopenia) to an anticoagulant
- •13. Creatinin clearance <30 mL/min, hypersensitivity to contrast media,
- •hypersensitivity to enoxaparin sodium
- •14. Active hepatic disease (defined as transaminase >3 X ULN or bilirubin > 1.5
- •ULN) or history of hepatic insufficiency
- •15. Known drug or alcohol abuse
- •16. Active malignant disease or current cytostatic treatment
- •17. Participation in an investigational drug study within the past 30 days or previous
- •participation in this trial
- •18. Any condition which in the opinion of the investigator would put the patient at
- •increased risk from participating in the study
- •19. Scheduled invasive or surgical procedure within 8 weeks after surgery
- •20. Brain, spinal, or ophthalmological invasive surgery within the previous 3 months
- •before enrolment
研究者
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