Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy: A Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 387
- 主要终点
- blood loss
研究概览
简要总结
To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.
详细描述
To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.
Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group
- Vasopressin group Just before beginning of AH, patients in this group will be injected with a 10-ml syringe containing 10 units of VP (5 mL bilaterally), 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder. If this site is not accessible, patients will be alternatively injected in the midline at the fundus (Okin et al., 2001). In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
- Tranexamic acid group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. Just before closure of peritoneum, 1.5 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface (Mitra et al., 2022).
- Control group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
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
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.
排除标准
- •history of coagulation or bleeding disorders or
- •if they were under antithrombotic treatment.
- •associated malignancy, renal impairment or allergy to TA.
研究组 & 干预措施
Vasopressin group
patients in this group will be injected with a 10-ml syringe containing 10 units of vasopressin (5 mL bilaterally)
干预措施: Vasopressin (Drug)
Tranexamic acid group
patients in this group will be injected with a 10-ml syringe containing 10 ml of tranexamic acid (5 mL bilaterally).
干预措施: Tranexamic acid (Drug)
Control group
patients in this group will be injected with a 10-ml syringe containing 10 ml of normal saline (5 mL bilaterally).
干预措施: Saline (Other)
结局指标
主要结局
blood loss
时间窗: 24 hours
Amount of blood loss in mL
次要结局
未报告次要终点
研究者
Warda Demerdash Khalifa Ali
Principal investigator
Al-Azhar University