A Randomized, Controlled, Open Label Study of the Efficacy and Safety of the Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin) Versus HeparinTM (Unfractionated Heparin) for Prevention of Venous Thromboembolism (VTE) in Gynecologic Oncology Patients
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Prophylactic treatment will start from surgery until the patients are discharged from the hospital(18). Then each patient will have 2 follow up visit in gyne- oncology clinic. The first visit will be 2 weeks from discharge & the second visit will be 3 months after surgery. In each visit patient will be evaluated for any evidence of thrombo-embolic events clinically & radiologically if needed ( spiral CT, V/Q scan & lower limp Doppler ). Any side effect or adverse reaction will be reported & it will be evaluated if it is related to the drug used or not.
详细描述
This study is a phase IIIB, randomized, open label, non-comparative controlled trial, and prospectively enrolling 150 females to assess the efficacy and safety of the Enoxaparin (Group A) and Unfractionated Heparin (Group B) for Gynecologic Oncology Patients In the Kingdom of Saudi Arabia who required surgery or admission for the prevention of VTE.
Patients who meet the Inclusion Criteria and signed an informed consent will be randomly assigned to 1 of the 2 treatment groups (Group A or Group B). Subjects will be assigned consecutive study numbers according to a predetermined random code generated by the Biostatistician. The randomisation will be based on a 1:1 ratio.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cancer patients aged 18 years or older were admitted with diagnosis of malignancy or suspension of malignancy and going for major surgery.
- •Patient with the following conditions:
- •Any patient were admitted with diagnosis of Gynecologic malignancy & going for major surgery such as laparotomies & abdominal hysterectomy OR
- •All staging laparotomies done for suspected ovarian malignancy by either ultrasound finding or tumor markers (raised CA 125) & found to be either borderline or benign ovarian tumor
- •Signed the Informed Consent Form
排除标准
- •1 Renal failure assessed by serum creatinine > 2.0mg/dL (180 mmol/L)
- •Patients on anticoagulant treatment in the previous 6 months
- •Bleeding disorders or platelet count < 80x109/L
- •Known hypersensitivity to unfractionated heparin or LMWHs
- •Pregnant women
- •Obese patients with body mass index ≥ 47
研究组 & 干预措施
Lovenox
Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)
干预措施: Enoxaparin, Heparin (Drug)
Heparin
Group B:HeparinTM (Unfractionated Heparin)
干预措施: Enoxaparin, Heparin (Drug)
结局指标
主要结局
Safety
时间窗: 3 years
Efficacy will be measured by measuring any thromboembolic events confirmed by objective testing such as spiral CT or V/Q scan and Doppler ultrasound as well as coagulation profile parameter, clinical sign and symptoms within 3 months post-operation.
次要结局
- Safety(3 years)