NCT05427513招募中早期 1 期
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss and Associated Complications in Bone Sarcoma Patients Treated With Limb Salvage Surgery: A Randomized Controlled Trial
Shaukat Khanum Memorial Cancer Hospital & Research Centre1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年4月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- blood loss
研究概览
简要总结
investigator will see the efficacy of tranexamic acid in limb salvage surgery patients which will prevent blood loss and help in conservation of blood products.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Limb sarcoma of upper and lower limb
- •Limb salvage
排除标准
- •liver insufficiency
- •renal insufficiency
- •allergic to drug
- •history of thromboembolic condition
- •pregnancy
- •metastatic disease
研究组 & 干预措施
placebo
Placebo Comparator
will injection 10 ml of normal saline to ensure binding
干预措施: normal saline (Other)
tranexamic acid(TXA)
Active Comparator
will inject tranexamic acid according to body weight
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
blood loss
时间窗: 72 hour post operatively
measure by hemoglobin direct method
no of blood transfused
时间窗: 72 hour
measured by number of transfusion
次要结局
- duration of hospital stay(total hospital stay post operatively for 02 month)
- volume of drain out put(measure till drain out in 72 hour)
- thromboembolic events(observed for 6 week determine on out patient visits)
研究者
研究点 (1)
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