Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Estimated Blood Loss (EBL)
研究概览
简要总结
The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.
详细描述
To date, no novel or pharmacologic methods of reducing blood loss have been described for women at risk for placenta accreta. Intravenous tranexamic acid (TXA), a drug with anti-fibrinolytic activity, is routinely used in elective orthopedic and cardiac surgery to reduce blood loss. Intravenous tranexamic acid is currently FDA approved for use in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty to reduce peri- and post-operative blood loss and to reduce the need for blood transfusion. There has been growing interest in the application of tranexamic acid in obstetrics and gynecology. In multiple international studies, intravenous TXA has been shown to significantly reduce blood loss when given prophylactically with cesarean delivery or vaginal delivery without an increase in morbidity from adverse thrombotic events. TXA has not been studied in the particular population of patients requiring cesarean hysterectomy for placenta previa or accreta. This inexpensive, low risk medication has potential to greatly reduce perioperative morbidity and cost when used in a high risk obstetrical population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English and Spanish speaking pregnant women
- •Any order pregnancy (singleton, twin gestation, etc)
- •Suspected accreta based on ultrasound or MRI imaging studies
- •All women evaluated for placenta accreta and deemed to be high risk for this disease (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections
排除标准
- •Women less than 18 years of age
- •Women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke
- •Women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome
- •Women who do not have a good understanding of either English or Spanish will be excluded.
- •Women with defective color vision (color-blindness)
研究组 & 干预措施
Treatment Arm (Tranexamic Acid, or TXA)
Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.
干预措施: Tranexamic Acid (Drug)
Placebo Arm
Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant.
干预措施: Placebo Drug (Drug)
结局指标
主要结局
Estimated Blood Loss (EBL)
时间窗: 1-3 hours (will be determined at the completion of the surgery).
EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery \&/or cesarean hysterectomy).
次要结局
- Blood Transfusion (Number of Units Transfused) Intraoperatively(Pulled from operative note, completed by the time of discharge.)
研究者
Mallory Kremer
Principle Investigator, Clinical Instructor
University of California, San Francisco