CTRI/2013/02/003359已完成4 期
A Multicentre, Open Label, Prospective, Comparative Clinical Study to Evaluate the Efficacy and Safety of Heparin Injection 25000 IU Manufactured by Nirma limited (Nirlife Healthcare), India with HEP (Heparin Injection) 25000 IU Manufactured by Gland Pharma Limited, India for Prophylaxis and Treatment as Anticoagulant and Thrombolytic In Deep Vein Thrombosis and Pulmonary Embolism
irma Limited Nirlife Healthcare0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 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
入选标准
- •Patients with any one of the following condition:
- •For prevention of clotting in arterial and heart surgery or
- •For prevention of postoperative deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease or
- •Prophylaxis and treatment of PE or
- •Prophylaxis and treatment of peripheral arterial embolism
排除标准
- •1. Patients with bleeding disorders and those having brain or spinal cord surgery, spinal anaesthesia, eye surgery, or potentially sanguineous operations.
- •2. Patient admitted with a primary diagnosis of trauma.
- •3. Patient admitted to neurosurgery or requires a neurosurgical procedure.
- •4. Patients having platelets < 125,000 mm3.
- •5. Patients with disorders of hemostasis (INR > 1.40).
- •6. Patients with renal dysfunction (serum creatinine > 1.50).
- •7. Patients with deep hyperthermia.
- •8. Patients with values for serum glutamic pyruvic transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) >2 times upper limit of normal (ULN).
- •9. Patients with history of heparin-induced thrombocytopenia.
- •10. Previous use (15 days before study start) of oral anticoagulants or expected use during the study.
- •11. Patients on current full anticoagulation medications including a heparin drip or warfarin
- •12. Use of any antiplatelet drugs (thienopyridine like drugs and aspirin) for less than 5 days.
- •13. Use of low molecular weight heparin for less than 24 hours or Use of non-fractioned heparin for less than 12 hours.
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