EUCTR2010-023383-40-PL进行中（未招募）不适用
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase IIb, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study
ThromboGenics N.V0 个研究点目标入组 600 人开始时间: 2011年5月11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
- 600
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 subjects aged = 18 years old scheduled for elective total hip replacement surgery.
- •2. Written informed consent.
- •3. 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
- •1. Male or female subjects aged = 18 years old scheduled for elective total hip replacement surgery.
- •2. Written informed consent.
- •3. 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1. Pregnancy at the time of screening based on a urine or blood pregnancy test or not using a reliable method of birth control.
- •2. Indication for anticoagulation other than post-operative thromboprophylaxis.
- •3. Active bleeding or high risk of bleeding contraindicating anticoagulant treatment according to the investigator.
- •4. Anticipated continued use of neuraxial catheter after surgery.
- •5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT such that anticoagulation is contraindicated according to the investigator
- •6. Uncontrolled hypertension according to the investigator.
- •7. Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
- •8. Creatinine clearance <30 mL/min.
- •9. Antiplatelet agents other than low dose aspirin (< 200 mg).
- •10. The use of intermittent pneumatic compression.
- •11. Known hypersensitivity to contrast media or rivaroxaban.
- •12. Known drug or alcohol abuse.
- •13. Active malignant disease or current cytostatic treatment.
- •14. Stroke within the previous month.
- •15. Participation in an investigational drug study within the past 30 days or previous participation in this study.
- •16. Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.
- •1. Pregnancy at the time of screening based on a urine or blood pregnancy test or not using a reliable method of birth control.
- •2. Indication for anticoagulation other than post-operative thromboprophylaxis.
- •3. Active bleeding or high risk of bleeding contraindicating anticoagulant treatment according to the investigator.
- •4. Anticipated continued use of neuraxial catheter after surgery.
- •5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT such that anticoagulation is contraindicated according to the investigator
- •6. Uncontrolled hypertension according to the investigator.
- •7. Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
- •8. Creatinine clearance <30 mL/min.
- •9. Antiplatelet agents other than low dose aspirin (< 200 mg).
- •10. The use of intermittent pneumatic compression.
- •11. Known hypersensitivity to contrast media or rivaroxaban.
- •12. Known drug or alcohol abuse.
- •13. Active malignant disease or current cytostatic treatment.
- •14. Stroke within the previous month.
- •15. Participation in an investigational drug study within the past 30 days or previous participation in this study.
- •16. Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.
研究者
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