EUCTR2005-002270-29-CZ进行中（未招募）不适用
Safety profile of innohep versus subcutaneous unfractionated Heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis - innohep in Renal Insufficiency Study (IRIS)
EO Pharma A/S0 个研究点目标入组 900 人开始时间: 2007年5月17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
- 900
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. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out
- •2. Patients with a symptomatic and objectively confirmed VTE (lower limb DVT or PE) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hours prior to randomisation).
- •3. Patients with an indication for DVT treatment with SC LMWH or UFH followed by OAC for at least 90 Days
- •4. Hospitalised patients who, during SC anticoagulant treatment would be followed, as specified in the protocol, on a daily basis either in hospital or in an out-patient setting
- •5. Patients at, or more than, 75 years with a creatinine clearance = 60 mL/min calculated according to the Cockcroft-Gault formula or
- •Patients at, or more than, 70 years with a creatinine clearance = 30 mL/min calculated according to the Cockcroft-Gault formula
- •6. Male or female
- •7. Any ethnic origin
- •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. Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation
- •2. Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation
- •3. Patients with a symptomatic VTE requiring thrombolytic therapy or invasive intervention
- •4. End Stage Renal Disease patients requiring dialysis
- •5. Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period
- •6. Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40/70 at randomisation and during the SC anticoagulant treatment period
- •7. Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)
- •8. Patients with a platelet count < 100.000.000.000/L
- •9. Patients with a known history of heparin-induced thrombocytopenia
- •10. Patients with known severe hepatic insufficiency manifested in a INR = 1,5
- •11. Patients with an uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg at at least 2 measurements within 24 hours prior to randomisation
- •12. Patients with ischaemic stroke at or within the last 1 week prior to randomisation
- •13. Patients with a known haemorrhagic stroke within 3 months prior to randomisation
- •14. Patients with a known bacterial endocarditis within 3 months prior to randomisation
- •15. Known or suspected hypersensitivity to component(s) of Investigational Products.
- •16. Current participation in any other interventional clinical trial
- •17. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 1 month
- •18. Patients previously randomised in this trial
- •19. Patients known or suspected of not being able to comply with the trial protocol
研究者
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