NCT00934167Unknown2 期
NON CLINICAL INFERIORITY OF HEPARIN SODIUM PRODUCED BY HIPOLABOR FARMACEUTICA LTDA COMPARED TO THE HEPARIN SODIUM PRODUCED BY APP PHARMACEUTICALS IN VENOUS THROMBOEMBOLISM PROPHYLAXIS, IN SURGICAL PATIENTS WITH MEDIUM RISK FOR DEVELOPMENT OF THROMBOEMBOLISM.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Non-appearance of venous thromboembolism
研究概览
简要总结
The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accept all items described in IC signing it in two ways;
- •Be aged between 18 and 60;
- •Be alert to the need for surgery antithrombotic prophylaxis;
- •Be classified as "moderate risk" for developing VTE, according to the protocol of prophylaxis of deep vein thrombosis of the Brazilian Society of Angiology and Vascular Surgery.
排除标准
- •Acute coronary syndrome, it will make use of anticoagulation;
- •Immobilization of the lower limbs due to fractures, because in this way will be considered as high risk;
- •History of recent stroke;
- •Patients at high risk of bleeding in which the use of heparin is contra-indicated;
- •General Surgery in patients over 60 years in the case of patients at high risk for VTE;
- •general surgery in patients 40 to 60 years with additional risk factors for development of VTE;
- •Major amputations;
- •More orthopedic surgeries;
- •Patients with pre-surgical diagnosis of malignant neoplasms;
- •Patients with a platelet level below 100x109 / L;
- •Use of anticoagulants 48 hours before randomization;
- •Severe liver failure;
- •Be classified as "Low Risk" or "high risk" for developing VTE, according to Maffei et al. (2005);
- •Pregnancy and lactation.
研究组 & 干预措施
Test
Experimental
Hipolabor
干预措施: heparin sodium - Hipolabor (Biological)
Comparator
Active Comparator
5.000 USP/mL - APP
干预措施: Heparin sodium - APP (Biological)
结局指标
主要结局
Non-appearance of venous thromboembolism
时间窗: 2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal FailureChronic Renal FailureNCT00828776Azidus Brasil62
Unknown
1 期
PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (SUBCUTANEOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALSHealthyNCT01652638Azidus Brasil44
Unknown
1 期
PHARMACODYNAMICS ASSESSMENT PRODUCT HEPARIN SODIUM (INTRAVENOUSLY) OF THE SWINE 5.000UI/ML OF BLAU FARMACÊUTICA S/A IN HEALTHY SUBJECTS IN COMPARISON OF SODIUM HEPARIN APP PHARMACEUTICALSHealthyNCT01651923Azidus Brasil60
Unknown
3 期
Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.ThrombusNCT00914472Azidus Brasil120
已完成
不适用
Examination of usefulness and safety of heparinoid agent based external medicine (over counter drug) for facial dryness symptom.facial dryness symptomJPRN-UMIN000018986Osaka city university graduate school of medicine, department of dermatology50