Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11,000
- 试验地点
- 23
- 主要终点
- Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells
研究概览
简要总结
A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
详细描述
Obstetrical hemorrhage is a common cause of maternal morbidity and mortality worldwide. The frequency and severity of hemorrhage is significantly higher after cesarean delivery than vaginal delivery. Recent evidence has emerged about the importance of the fibrinolytic pathway in the pathophysiology of hemorrhage in different clinical scenarios including trauma-associated bleeding, cardiovascular surgery, and obstetrical hemorrhage. Tranexamic acid (TXA) inhibits fibrinolysis and is used routinely to prevent hemorrhage in trauma cases and high risk surgeries. Randomized trials of TXA as a prophylaxis to prevent hemorrhage in cesarean delivery have been small and of mixed quality; however meta-analysis suggests that it is effective.
This study is a randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
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)
盲法说明
The patient nor the clinical staff will be aware of the treatment assignment. The TXA or placebo solutions will be prepared by the center research pharmacies.
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
- •Scheduled or unscheduled cesarean delivery
- •Singleton or twin gestation
排除标准
- •Age less than 18 years
- •Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative hemorrhage
- •Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated
- •Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis
- •Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and its use has been associated with postoperative seizures
- •Serum creatinine 1.2 or higher or on dialysis, with renal disease, or a history of renal insufficiency, because TXA is substantially excreted by the kidney, and impaired renal function may increase the risk of toxic reactions.
- •Sickle cell disease, because of substantial use of perioperative transfusion unrelated to hemorrhage. Sickle cell trait is not an exclusion per se.
- •Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism
- •Need for therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA
- •Treatment with clotting factor concentrates, because the risk of thrombosis may be increased with TXA
- •Presence of frank hematuria, because the risk of ureteral obstruction in those with upper urinary tract bleeding may be increased with TXA
- •Patient refusal of blood products because the primary outcome is then pre-determined
- •Receipt of TXA; or planned or expected use of TXA prophylaxis
- •Active cancer, because of risk of thromboembolism
- •Congestive heart failure requiring treatment, because of risk of thrombosis
- •History of retinal disease, because the risk of central retinal artery or vein obstruction may be increased with TXA
- •Acquired defective color vision or subarachnoid hemorrhage, since TXA is contraindicated
- •Hypersensitivity to TXA or any of the ingredients
- •No hemoglobin result available from the last 4 weeks, since it is necessary to measure the post-operative change in hemoglobin
- •Scheduled cesarean delivery and quota for scheduled deliveries already met. Quotas on the number of scheduled and unscheduled deliveries will be placed to ensure approximately equal distribution of scheduled and unscheduled cesarean deliveries.
- •Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
- •Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
- •Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
- •Symptomatic for COVID-19 infection within 14 days prior to delivery
研究组 & 干预措施
Placebo
Normal saline for intravenous administration
干预措施: Placebo (Drug)
Tranexamic Acid
Tranexamic Acid for intravenous administration
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells
时间窗: by hospital discharge or by 7 days postpartum, whichever is sooner
Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver).
次要结局
- Number of Participants Who Received Surgical or Radiologic Interventions to Control Bleeding and Related Complications(within 7 days postpartum)
- Number of Participants Who Received Open Label TXA or Other Antifibrinolytic(within 7 days postpartum)
- Number of Mothers Who Died or Had Thromboembolic Events (Venous or Arterial), Ischemic Stroke, Myocardial Infarction, New-onset Seizure Activity, or Were Admitted to the Intensive Care Unit for More Than 24 Hours(within 6 weeks postpartum)
- Number of Participants Who Were Transfused With Other Blood Products(within 7 days postpartum)
- Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery(From skin incision to transfer from operating room, average of 1 hour)
- Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment(within 6 weeks postpartum)
- Number of Participants With Postpartum Infectious Complications(within 6 weeks postpartum)
- Change in Hemoglobin(from 4 weeks before delivery to 48 hours postpartum)
- Length of Stay(Until hospital discharge, an average of 3 days)
- Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells(within 7 days postpartum)
- Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction(within 6 weeks postpartum)
- Number of Participants Who Were Treated With Uterotonics Other Than Oxytocin(within 48 hours postpartum)
- Number of Participants Who Received Treatments and Interventions in Response to Bleeding and Related Complications(within 7 days postpartum)