PER-052-01已完成未知
PROFILAXIS OF VENOUS THROMBOEMBOLISM IN PATIENTS WITH ACUTE MEDICAL CONDITIONS REQUIRING PROLONGED IMMOBILIZATION: A COMPARISON OF THERAPINE (FRAGMIN) 5000 U. VERSUS PLACEBO IN A DOUBLE BLIND STUDY RANDOMIZED MULTICENTER
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,0 个研究点目标入组 0 人开始时间: 2001年8月3日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Age:> 40 years of age.
- •Acute medical condition requiring a planned stay in the hospital> 4 days.
- •Recent immobilization (<3 days) defined as patients confined to bed during waking hours.
- •Signed informed consent.
- •Patients hospitalized for at least one of the following reasons:
- •Congestive heart failure (NYHA class III or IV) or acute respiratory failure not requiring support ventilation
排除标准
- •Previously randomized within this study.
- •Active participation known in another study in the process of research drugs or device protocol or during the past 30 days.
- •TVP / EP in the inclusion.
- •Hospitalization due to acute coronary syndrome (ACS) present or within the last month.
- •Anticipated procedure for major or invasive surgery (including epidural anesthesia or lumbar puncture) within the next 2 weeks.
- •Major or invasive surgery procedure within the last month.
- •Lumbar puncture and / or spinal / epidural anesthesia (including internal catheter) within the last 24 hours.
- •Bacterial endocarditis.
- •Lower limb immobilization due to cast or fracture splint.
- •Anticoagulation (other than LMWH or heparin) / direct thrombin inhibitors / thrombolytic therapy administered or completed within one week of randomization.
- •Prophylaxis with heparin or low molecular weight heparin (LMWH) administered less than 48 hours before inclusion.
- •Acute cerebrovascular accident within 3 months before entering the study.
- •Known bleeding bleeding or clinically significant coagulopathy.
- •Active major hemorrhage (see definition of protocol) within 3 months before entering the study.
- •Platelet count <100 x 10 9 / L
- •Known renal insufficiency (that is, serum creatinine> 200 umol / L or> 2.3 mg / dL).
- •Known hepatic insufficiency or active hepatitis defined as: transaminases (AST (TGOS), ALAT (TGPS))> 3 X ULN (upper normal limit).
- •serum albumin <3.5 g / dL or 35 g / L.
- •High prothrombin time (TNI> 1.5)
- •Jaundice (total bilirubin> 2.0 mg / dL or 34.2 umol / L).
- •History of hepatic encephalopathy.
- •History of ascites.
- •Known infection of the human immunodeficiency virus.
- •Uncontrolled hypertension (systolic blood pressure> 200 mmHg, diastolic blood pressure> 120 mmHg, or both).
- •Heparin-induced thrombocytopenia / LMWH experienced previously and / or known sensitivity to heparin.
- •Known pregnancy or breastfeeding.
- •Inability to follow the protocol and comply with the monitoring requirements.
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