EUCTR2005-002270-29-DK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: 2005年12月12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
- 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 DVT (distal or proximal) with or without PE objectively confirmed by a positive ultrasonography or venography (performed 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, will be followed, as specified in the protocol, on a daily basis either in hospital or in an out-patient setting
- •5. Patients with a creatinine clearance = 60 mL/min calculated according to the Cockcroft-Gault formula
- •6. Age equal to or more than 75 years
- •7. Male or female
- •8. 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 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 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 (e.g. cognitive impairment, alcoholism, drug dependency or psychotic state).
研究者
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