Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- Evidences of clinical thromboembolic disease after gynaecological surgeries
研究概览
简要总结
The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women who undergo gynecologic surgery for benign conditions world wide and especially in developing countries including our region. Having a research in our locality for the first time might raise awareness of the importance of VTE prophylaxis.
详细描述
Deep vein thrombosis (DVT) and pulmonary embolism (PE), also referred to as venous thromboembolic events (VTE), are two major complications after gynaecological surgeries that can result in significant morbidity and mortality. The incidence of VTE after gynaecologic surgery varies depending on the method used for diagnosis. The rate of clinical DVT is estimated to be 3% after gynaecological surgery if no thromboprophylaxis was used. The rate of VTE assumed to decrease to 0.4% if Low molecular weight heparin was used as a thromboprophylaxis.
According to our knowledge there are no published researches on the effect of the new second generation Low molecular Weight Heparin Bemiparin as a thromboprophylaxis after benign gynaecological surgery in comparison to a control group.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female undergoing Benign gynecological surgeries.
- •Having moderate,high and very high risk factors for venous thromboembolism.
- •No contraindications for the use of Heparin.
排除标准
- •Having mild risk factors for thromboembolism.
- •Active vaginal bleeding.
- •Thrombocytopaenia.
- •any patient who is already on anticoagulant.
- •Sever renal or Liver diseases.
研究组 & 干预措施
Bemiparin
group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
干预措施: Bemiparin (Drug)
结局指标
主要结局
Evidences of clinical thromboembolic disease after gynaecological surgeries
时间窗: within the first 30 days after surgery the first 30 days
to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries
次要结局
- to determine the side effects of Bemiparin injection(after receiving the injections and up to 30 days after surgery)
研究者
Assistant Prof. Shahla Alalaf
Assistant Professor
Hawler Medical University